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SRL2012-055 In Vitro Evaluation of the Critical Wavelength of
Sunscreen Products Final Report
February 9 2012 Objective To evaluate the critical wavelength of sunscreen
products after irradiation with a full spectrum UV dose of 4 MEDs (800 effective Jm2) according to the FDA Final Rule of June 17 2011
Test Product Lip Balm (Acai) ndash Formula Results The test product Lip Balm (Acai) ndash Formula
had a mean Critical Wavelength of 372 nm after a full spectrum UV dose of 4 MEDs (800 effective Jm2) indicating that the formula meets the requirements for labeling as ldquoBroad Spectrumrdquo [1]
Sponsor Supergoop Holly Thaggard CEO amp Founder Investigator Joseph W Stanfield M S Investigator
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Suncare Research Laboratories LLC SRL2012-055 2518-B Reynolda Road Lip Balm (Acai) - Formula Winston Salem NC 27106 Supergoop (336) 725-6501 FDA Final Rule Critical Wavelength (336) 725-6503 fax
Figure 2 Mean Percent Area under the Absorbance Curve between 290 and 400 nm after a Full-Spectrum UV Dose of 4 MEDs (800 effective Jm2)
100
90
80
70
60IV QJ 50laquo ~ 40
30
20
10 shy
0
Area
~ ~
--
290 300 310 320 330 340 350 360 370 380 390 400
Wavelength (nm)
Conclusion The mean Critical Wave length was 372 nm (SD=058 CV=O16) after a full-spectrum UV dose of 4 MEDs (800 effective Jm2) The test product meets the requirements for labeling as Broad Spectrum [lJ
- InvestigatorW Stanfield MS
References 1 Broad Spectrum Test Procedure US Food and Drug
Administration 21 CFR Parts 201 and 310 Federal Register Vol 76 No 117 Friday June 17 2011 pp 35620-35665
2 Diffey BL A method for broad spectrum classification of sunscreens Int J Cosmet Sci 19941647-52
6
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SRL2012-055 Evaluation of the Static Sun Protection Factor (SPF) of Sunscreen-Containing Formulas According to the FDA Final Rule [1]
February 27 2012 Final Report
Objective To measure the static sun protection factor (SPF) of over-
the-counter (OTC) sunscreen-containing formulas according to the FDA Final Rule [1]
Test Product Lip Balm (Acai) ndash Formula Study Dates February 13 2012 to February 18 2012 Results Ten subjects completed the test The mean static SPF of the
test product Lip Balm (Acai) ndash Formula was 3255 (n=10 SD=340) The test product
meets FDA Final Rule requirements for labeling as Static SPF 30 [1]
Sponsor Trsquos Supergoop 5 Holly Thaggard CEO amp Founder Investigator Joseph W Stanfield M S
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Table 1 Subject Demographic and Static SPF Results for Lip Balm (Acai) ‐ Formula and 7 Padimate3 Oxybenzone Standard
Tech Initals Subject SRL ID Initials Age Sex Skin Type MEDuI (eff Jm2) MEDuR (eff Jm2) tpMEDp (eff Jm2) SPF ssMEDp (eff Jm2) SPFAOS 01 3014 ADS 27 F II 17850 18111 535811 2958 291200 1608AOS 02 2474 JSV 27 M I lt11667 11339 350100 3088 218928 1931AOS 03 3016 MLH 34 F I 9839 9450 256933 2719 184022 1947AOS 04 3019 MAL 20 F III 21339 21583 735889 3410 399900 1853AOS 05 3020 RSM 44 M III lt9411 9056 324500 3583 176400 1948AOS 06 3021 JDH 20 M III 19922 16300 597600 3666 282600 1734AOS 07 2070 WJL 61 M II 18667 18550 643950 3471 349761 1886AOS 08 693 BSI 48 M I 14867 14667 513333 3500 242544 1654AOS 09 3023 CLF 56 M III 18222 18700 628933 3363 297467 1591AOS 10 3024 SAS 39 M III 20700 16906 471606 2790 293622 1737
Mean= 3760 Mean= 3255 1789SD= 1451 SD= 340 141
n= 10 n= 10 10SE= 107 045
t= 226 226Labeled SPF = 30 16
Mean Valid (YN) YesLabeled Valid (YN) Yes
Lip Balm (Acai) Formula
7 Padimate-O3 Oxybenzone Standard
SRL2012-055 Supergoop
5
CONFIDENTIALCONFIDENTIAL
CONFIDENTIAL
Suncare Research Laboratories LLC SRL2012-055 2518-B Reynolda Road Up Balm (Acai) Winston Salem NC 27106 Formula (336) 725-6501 Supergoop (336) 725-6503 fax FDA Final Rule Static SPF
Adverse Events No Adverse Events were reported
Conclusion The test product Lip Balm (Acai) - Formula meets the FDA Final Rule requirements for labeling as Static SPF 30 [1]
W Stanfield M S Zz-d-uz-
- Investigator Date
References
1 U S Food and Drug Administration Labeling and Effectiveness Testing Sunscreen Drug Products for Over-the-Counter Human Use Final Rule 21 CFR Parts 201 and 310 Federal Register Vol 76 No 117 June 17 2011 pp 35660-35665
2 Guideline for the colorimetric determination of skin color typing and prediction of the minimal erythema dose (MED) without UV exposure Colipa 2007
6
CONFIDENTIAL
CONFIDENTIALCONFIDENTIAL
Suncare Research Laboratories LLC SRL2012-055 2518-B Reynolda Road Lip Balm (Acai) - Formula Winston Salem NC 27106 Supergoop (336) 725-6501 FDA Final Rule Critical Wavelength (336) 725-6503 fax
Figure 2 Mean Percent Area under the Absorbance Curve between 290 and 400 nm after a Full-Spectrum UV Dose of 4 MEDs (800 effective Jm2)
100
90
80
70
60IV QJ 50laquo ~ 40
30
20
10 shy
0
Area
~ ~
--
290 300 310 320 330 340 350 360 370 380 390 400
Wavelength (nm)
Conclusion The mean Critical Wave length was 372 nm (SD=058 CV=O16) after a full-spectrum UV dose of 4 MEDs (800 effective Jm2) The test product meets the requirements for labeling as Broad Spectrum [lJ
- InvestigatorW Stanfield MS
References 1 Broad Spectrum Test Procedure US Food and Drug
Administration 21 CFR Parts 201 and 310 Federal Register Vol 76 No 117 Friday June 17 2011 pp 35620-35665
2 Diffey BL A method for broad spectrum classification of sunscreens Int J Cosmet Sci 19941647-52
6
CONFIDENTIALCONFIDENTIAL
SRL2012-055 Evaluation of the Static Sun Protection Factor (SPF) of Sunscreen-Containing Formulas According to the FDA Final Rule [1]
February 27 2012 Final Report
Objective To measure the static sun protection factor (SPF) of over-
the-counter (OTC) sunscreen-containing formulas according to the FDA Final Rule [1]
Test Product Lip Balm (Acai) ndash Formula Study Dates February 13 2012 to February 18 2012 Results Ten subjects completed the test The mean static SPF of the
test product Lip Balm (Acai) ndash Formula was 3255 (n=10 SD=340) The test product
meets FDA Final Rule requirements for labeling as Static SPF 30 [1]
Sponsor Trsquos Supergoop 5 Holly Thaggard CEO amp Founder Investigator Joseph W Stanfield M S
CONFIDENTIAL
CONFIDENTIALCONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
Table 1 Subject Demographic and Static SPF Results for Lip Balm (Acai) ‐ Formula and 7 Padimate3 Oxybenzone Standard
Tech Initals Subject SRL ID Initials Age Sex Skin Type MEDuI (eff Jm2) MEDuR (eff Jm2) tpMEDp (eff Jm2) SPF ssMEDp (eff Jm2) SPFAOS 01 3014 ADS 27 F II 17850 18111 535811 2958 291200 1608AOS 02 2474 JSV 27 M I lt11667 11339 350100 3088 218928 1931AOS 03 3016 MLH 34 F I 9839 9450 256933 2719 184022 1947AOS 04 3019 MAL 20 F III 21339 21583 735889 3410 399900 1853AOS 05 3020 RSM 44 M III lt9411 9056 324500 3583 176400 1948AOS 06 3021 JDH 20 M III 19922 16300 597600 3666 282600 1734AOS 07 2070 WJL 61 M II 18667 18550 643950 3471 349761 1886AOS 08 693 BSI 48 M I 14867 14667 513333 3500 242544 1654AOS 09 3023 CLF 56 M III 18222 18700 628933 3363 297467 1591AOS 10 3024 SAS 39 M III 20700 16906 471606 2790 293622 1737
Mean= 3760 Mean= 3255 1789SD= 1451 SD= 340 141
n= 10 n= 10 10SE= 107 045
t= 226 226Labeled SPF = 30 16
Mean Valid (YN) YesLabeled Valid (YN) Yes
Lip Balm (Acai) Formula
7 Padimate-O3 Oxybenzone Standard
SRL2012-055 Supergoop
5
CONFIDENTIALCONFIDENTIAL
CONFIDENTIAL
Suncare Research Laboratories LLC SRL2012-055 2518-B Reynolda Road Up Balm (Acai) Winston Salem NC 27106 Formula (336) 725-6501 Supergoop (336) 725-6503 fax FDA Final Rule Static SPF
Adverse Events No Adverse Events were reported
Conclusion The test product Lip Balm (Acai) - Formula meets the FDA Final Rule requirements for labeling as Static SPF 30 [1]
W Stanfield M S Zz-d-uz-
- Investigator Date
References
1 U S Food and Drug Administration Labeling and Effectiveness Testing Sunscreen Drug Products for Over-the-Counter Human Use Final Rule 21 CFR Parts 201 and 310 Federal Register Vol 76 No 117 June 17 2011 pp 35660-35665
2 Guideline for the colorimetric determination of skin color typing and prediction of the minimal erythema dose (MED) without UV exposure Colipa 2007
6
CONFIDENTIAL
CONFIDENTIALCONFIDENTIAL
SRL2012-055 Evaluation of the Static Sun Protection Factor (SPF) of Sunscreen-Containing Formulas According to the FDA Final Rule [1]
February 27 2012 Final Report
Objective To measure the static sun protection factor (SPF) of over-
the-counter (OTC) sunscreen-containing formulas according to the FDA Final Rule [1]
Test Product Lip Balm (Acai) ndash Formula Study Dates February 13 2012 to February 18 2012 Results Ten subjects completed the test The mean static SPF of the
test product Lip Balm (Acai) ndash Formula was 3255 (n=10 SD=340) The test product
meets FDA Final Rule requirements for labeling as Static SPF 30 [1]
Sponsor Trsquos Supergoop 5 Holly Thaggard CEO amp Founder Investigator Joseph W Stanfield M S
CONFIDENTIAL
CONFIDENTIALCONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
CONFIDENTIAL
Table 1 Subject Demographic and Static SPF Results for Lip Balm (Acai) ‐ Formula and 7 Padimate3 Oxybenzone Standard
Tech Initals Subject SRL ID Initials Age Sex Skin Type MEDuI (eff Jm2) MEDuR (eff Jm2) tpMEDp (eff Jm2) SPF ssMEDp (eff Jm2) SPFAOS 01 3014 ADS 27 F II 17850 18111 535811 2958 291200 1608AOS 02 2474 JSV 27 M I lt11667 11339 350100 3088 218928 1931AOS 03 3016 MLH 34 F I 9839 9450 256933 2719 184022 1947AOS 04 3019 MAL 20 F III 21339 21583 735889 3410 399900 1853AOS 05 3020 RSM 44 M III lt9411 9056 324500 3583 176400 1948AOS 06 3021 JDH 20 M III 19922 16300 597600 3666 282600 1734AOS 07 2070 WJL 61 M II 18667 18550 643950 3471 349761 1886AOS 08 693 BSI 48 M I 14867 14667 513333 3500 242544 1654AOS 09 3023 CLF 56 M III 18222 18700 628933 3363 297467 1591AOS 10 3024 SAS 39 M III 20700 16906 471606 2790 293622 1737
Mean= 3760 Mean= 3255 1789SD= 1451 SD= 340 141
n= 10 n= 10 10SE= 107 045
t= 226 226Labeled SPF = 30 16
Mean Valid (YN) YesLabeled Valid (YN) Yes
Lip Balm (Acai) Formula
7 Padimate-O3 Oxybenzone Standard
SRL2012-055 Supergoop
5
CONFIDENTIALCONFIDENTIAL
CONFIDENTIAL
Suncare Research Laboratories LLC SRL2012-055 2518-B Reynolda Road Up Balm (Acai) Winston Salem NC 27106 Formula (336) 725-6501 Supergoop (336) 725-6503 fax FDA Final Rule Static SPF
Adverse Events No Adverse Events were reported
Conclusion The test product Lip Balm (Acai) - Formula meets the FDA Final Rule requirements for labeling as Static SPF 30 [1]
W Stanfield M S Zz-d-uz-
- Investigator Date
References
1 U S Food and Drug Administration Labeling and Effectiveness Testing Sunscreen Drug Products for Over-the-Counter Human Use Final Rule 21 CFR Parts 201 and 310 Federal Register Vol 76 No 117 June 17 2011 pp 35660-35665
2 Guideline for the colorimetric determination of skin color typing and prediction of the minimal erythema dose (MED) without UV exposure Colipa 2007
6
CONFIDENTIAL
CONFIDENTIALCONFIDENTIAL
Table 1 Subject Demographic and Static SPF Results for Lip Balm (Acai) ‐ Formula and 7 Padimate3 Oxybenzone Standard
Tech Initals Subject SRL ID Initials Age Sex Skin Type MEDuI (eff Jm2) MEDuR (eff Jm2) tpMEDp (eff Jm2) SPF ssMEDp (eff Jm2) SPFAOS 01 3014 ADS 27 F II 17850 18111 535811 2958 291200 1608AOS 02 2474 JSV 27 M I lt11667 11339 350100 3088 218928 1931AOS 03 3016 MLH 34 F I 9839 9450 256933 2719 184022 1947AOS 04 3019 MAL 20 F III 21339 21583 735889 3410 399900 1853AOS 05 3020 RSM 44 M III lt9411 9056 324500 3583 176400 1948AOS 06 3021 JDH 20 M III 19922 16300 597600 3666 282600 1734AOS 07 2070 WJL 61 M II 18667 18550 643950 3471 349761 1886AOS 08 693 BSI 48 M I 14867 14667 513333 3500 242544 1654AOS 09 3023 CLF 56 M III 18222 18700 628933 3363 297467 1591AOS 10 3024 SAS 39 M III 20700 16906 471606 2790 293622 1737
Mean= 3760 Mean= 3255 1789SD= 1451 SD= 340 141
n= 10 n= 10 10SE= 107 045
t= 226 226Labeled SPF = 30 16
Mean Valid (YN) YesLabeled Valid (YN) Yes
Lip Balm (Acai) Formula
7 Padimate-O3 Oxybenzone Standard
SRL2012-055 Supergoop
5
CONFIDENTIALCONFIDENTIAL
CONFIDENTIAL
Suncare Research Laboratories LLC SRL2012-055 2518-B Reynolda Road Up Balm (Acai) Winston Salem NC 27106 Formula (336) 725-6501 Supergoop (336) 725-6503 fax FDA Final Rule Static SPF
Adverse Events No Adverse Events were reported
Conclusion The test product Lip Balm (Acai) - Formula meets the FDA Final Rule requirements for labeling as Static SPF 30 [1]
W Stanfield M S Zz-d-uz-
- Investigator Date
References
1 U S Food and Drug Administration Labeling and Effectiveness Testing Sunscreen Drug Products for Over-the-Counter Human Use Final Rule 21 CFR Parts 201 and 310 Federal Register Vol 76 No 117 June 17 2011 pp 35660-35665
2 Guideline for the colorimetric determination of skin color typing and prediction of the minimal erythema dose (MED) without UV exposure Colipa 2007
6
CONFIDENTIAL
CONFIDENTIALCONFIDENTIAL
Suncare Research Laboratories LLC SRL2012-055 2518-B Reynolda Road Up Balm (Acai) Winston Salem NC 27106 Formula (336) 725-6501 Supergoop (336) 725-6503 fax FDA Final Rule Static SPF
Adverse Events No Adverse Events were reported
Conclusion The test product Lip Balm (Acai) - Formula meets the FDA Final Rule requirements for labeling as Static SPF 30 [1]
W Stanfield M S Zz-d-uz-
- Investigator Date
References
1 U S Food and Drug Administration Labeling and Effectiveness Testing Sunscreen Drug Products for Over-the-Counter Human Use Final Rule 21 CFR Parts 201 and 310 Federal Register Vol 76 No 117 June 17 2011 pp 35660-35665
2 Guideline for the colorimetric determination of skin color typing and prediction of the minimal erythema dose (MED) without UV exposure Colipa 2007
6
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