Label: AVENE FACE SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 64760-782-01
- Packager: Pierre Fabre USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
Adults and children 6 months and older:
• Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • after 80 minutes of swimming or sweating • immediately after towel drying • Children under 6 months of age: Ask a doctor • 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 sunscreen 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. to 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses.
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Inactive Ingredients
Water/Eau/Aqua, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Tridecyl Salicylate, Polyglyceryl-3 Polyricinoleate, Glyceryl Stearate, Shea Butter Ethyl Esters, Sodium Chloride, Polyester-7, Silica, Neopentyl Glycol Diheptanoate, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxystearate, Glyceryl Dibehenate, Bisabolol, Phenylpropanol, Iron Oxides, Propanediol, Lecithin, Tribehenin, Allantoin, Caprylyl Glycol,Glyceryl Behenate, Coco-Caprylate, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyglyceryl-4
Diisostearate/ Polyhydroxystearate/Sebacate, Hydrogenated Lecithin, Sodium Hydroxide, Tocopherol. - Other information
- Questions?
- Box 337120
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INGREDIENTS AND APPEARANCE
AVENE FACE SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64760-782 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) LEVOMENOL (UNII: 24WE03BX2T) PHENYLPROPANOL (UNII: 0F897O3O4M) ALLANTOIN (UNII: 344S277G0Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) COCO-CAPRYLATE (UNII: 4828G836N6) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) WATER (UNII: 059QF0KO0R) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYESTER-7 (UNII: 0841698D2F) ISOAMYL LAURATE (UNII: M1SLX00M3M) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPANEDIOL (UNII: 5965N8W85T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIBEHENIN (UNII: 8OC9U7TQZ0) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64760-782-01 1 in 1 CARTON 05/01/2024 1 40 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/01/2024 Labeler - Pierre Fabre USA Inc. (117196928) Registrant - Pierre Fabre USA Inc. (117196928)
