Label: SUNSCREEN CREAM- avobenzone , homosalate ,octisalate , octocrylene lotion, augmented
- NDC Code(s): 84445-005-01
- Packager: Shenzhen Furuizhilian keji Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 16, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- DO NOT USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Dicaprylyl Carbonate, Diethylhexyl Butamido Triazone, Titanium Dioxide, C20-22 Alkyl Phosphate, Aluminum Starch Octenylsuccinate, C20-22 Alcohols, Arginine, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sodium Stearoyl Glutamate, Sodium Hydroxide, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Allantoin, Caprylyl Glycol, Tocopherol (Vitamin E), Stearyl Glycyrrhetinate, Polysorbate 60, Disodium EDTA, Fragrance, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Extract, Glucose, Potassium Sorbate
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN CREAM
avobenzone , homosalate ,octisalate , octocrylene lotion, augmentedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84445-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 g in 50 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.5 g in 50 g Inactive Ingredients Ingredient Name Strength C20-22 ALCOHOLS (UNII: O4M0347C6A) SODIUM HYDROXIDE (UNII: 55X04QC32I) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 1.0%) (UNII: 8Z5ZAL5H3V) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BEMOTRIZINOL (UNII: PWZ1720CBH) ARGININE (UNII: 94ZLA3W45F) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) COCOA (UNII: D9108TZ9KG) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISCOTRIZINOL (UNII: 2UTZ0QC864) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TOCOPHEROL (UNII: R0ZB2556P8) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) OCTINOXATE (UNII: 4Y5P7MUD51) ENSULIZOLE (UNII: 9YQ9DI1W42) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) FRAGRANCE 13576 (UNII: 5EM498GW35) POLYSORBATE 60 (UNII: CAL22UVI4M) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) PHENOXYETHANOL (UNII: HIE492ZZ3T) SQUALANE (UNII: GW89575KF9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84445-005-01 50 g in 1 TUBE; Type 0: Not a Combination Product 07/16/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/16/2024 Labeler - Shenzhen Furuizhilian keji Co., Ltd. (418598613) Establishment Name Address ID/FEI Business Operations Shenzhen Furuizhilian keji Co., Ltd. 418598613 manufacture(84445-005)