Label: COPPERSTONE WATER BABIES PURE AND SIMPLE WHIPPED SUNSCREEN BROAD SPECTRUM SPF 50 SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 23667-802-01
- Packager: Formulated Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 2, 2023
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- Drug Facts
- Active ingredients
- Uses
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Warnings
For external use only
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Directions
- apply liberally 15 minutes before sun exposure
- do not dispense or apply directly on face. Dispense into hands and apply to face
- use in well-ventillated areas
- reapply:
- after 80 minutes if swimming or sweating
- imediately after towel drying
- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscereen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other Information
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Inactive ingredients
Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Fragrance, Nitrous Oxide.
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INGREDIENTS AND APPEARANCE
COPPERSTONE WATER BABIES PURE AND SIMPLE WHIPPED SUNSCREEN BROAD SPECTRUM SPF 50 SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23667-802 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 40 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 g Inactive Ingredients Ingredient Name Strength ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) WATER (UNII: 059QF0KO0R) DOCOSANOL (UNII: 9G1OE216XY) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL ETHER (UNII: 77JZM5516Z) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) BENZYL ALCOHOL (UNII: LKG8494WBH) PALMITIC ACID (UNII: 2V16EO95H1) STEARIC ACID (UNII: 4ELV7Z65AP) MYRISTYL ALCOHOL (UNII: V42034O9PU) CHLORPHENESIN (UNII: I670DAL4SZ) TOCOPHEROL (UNII: R0ZB2556P8) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) LAURYL ALCOHOL (UNII: 178A96NLP2) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) NITROUS OXIDE (UNII: K50XQU1029) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23667-802-01 142 g in 1 CAN; Type 0: Not a Combination Product 02/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/09/2017 Labeler - Formulated Solutions, LLC (143266687)
