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UVA/UVB SPF 15 RODAN AND FIELDS- octinoxate, zinc oxide lotion Rodan & Fields LLC.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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UVA and UVB SPF 15 SunscreenActive Ingredients Purpose
Octinoxate 7.5% Sunscreen
Zinc Oxide 3.4% Sunscreen
Uses
Helps prevent sunburnHigher SPF gives more sun protectionTemporarily protects chapped or cracked skin.
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Centerimmediately.
when using this product keep out of eyes. Rinse with water to remove.
Directions
Apply a generous dime-sized amount evenly over entire face every morning
Children under 6 months of age: ask a doctor.
Reapply as needed or after towel drying, swimming, or sweating.
Water, Octyldodecanol, Hydrogenated polydecene, butylene glycol, dimethicone, sodiumdihydroxycetyl phosphate, glyceryl stearate, PEG-100 stearate, hydroxyethyl acrylate/sodiumacryloyldimethyl taurate copolymer, astrocaryum murumuru butter, Chamomilla recutita (matricaria)flower oil, Cucumis melo (melon) fruit extract, Persea Gratissima (avacado) oil, Cholesterol/Potassiumsulfate, Acetyl glucosamine, squalene, Cholesterol, Linoleic acid, Bisabolol, Tocopheryl Acetate,Oleth-3 phosphate, propylene glycol dicaprylate ethylhexylglycerin, caprylyl glycol,triethoxycaprylylsilane, polysorbate 60, boron nitride, xanthan gum, tetrasodium EDTA, citric acid,potassium sorbate, phenoxyethanol
50 mL/ 1.7 Fl. Oz.
UVA/UVB SPF 15 RODAN AND FIELDS octinoxate, zinc oxide lotion
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:14222-20 22
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
Rodan & Fields LLC.
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 10 0 mL
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.4 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
WATER (UNII: 0 59 QF0 KO0 R)
O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)
HYDRO GENATED PO LYDECENE ( 550 MW) (UNII: U333RI6 EB7)
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
DIMETHICO NE (UNII: 9 2RU3N3Y1O)
GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)
PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)
ASTRO CARYUM MURUMURU SEED BUTTER (UNII: 12V6 4UPU6 R)
CHAMO MILE FLO WER O IL (UNII: 6 0 F8 0 Z6 1A9 )
CANTALO UPE (UNII: 8 QF5D5H6 UH)
SQ UALENE (UNII: 7QWM220 FJH)
CHO LESTERO L (UNII: 9 7C5T2UQ7J)
O LETH-3 PHO SPHATE (UNII: 8 Q0 Z18 J1VL)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:14222-20 22-2 1 in 1 BOX
1 NDC:14222-20 22-1 50 mL in 1 BOTTLE
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part352 0 6 /0 3/20 11
Labeler - Rodan & Fields LLC. (051659584)
Registrant - Cosmetic Enterprises Ltd. (017701475)
EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations
Co smetic Enterprises Ltd. 0 1770 1475 manufacture
Revised: 1/2012