rodan and fields soothe - dailymed

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

Rodan and Fields

Soothe

UVA/UVB SPF 15 Sunscreen

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