Label: AUSTRALIAN GOLD INSTANT BRONZER SPF 4 SUNSCREEN- avobenzone, octocrylene spray
- NDC Code(s): 58443-0617-4
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 17, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
- Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging • For external use only
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Directions
- shake well before use • apply liberally 15 minutes before sun exposure and rub into skin • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor
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Inactive ingredients
Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Butylphthalimide, Caramel, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Isopropylphthalimide, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trimethylsiloxysilicate, Sodium Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Propylene Glycol, Polysorbate 20, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Fragrance (Parfum), Phenoxyethanol, Ethylhexylglycerin
- Other information
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- AUSTRALIAN GOLD INSTANT BRONZER 4 SPRAY GEL SUNSCREEN
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD INSTANT BRONZER SPF 4 SUNSCREEN
avobenzone, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0617 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 9.9 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) DIMETHICONE (UNII: 92RU3N3Y1O) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARAMEL (UNII: T9D99G2B1R) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) WATER (UNII: 059QF0KO0R) SUNFLOWER OIL (UNII: 3W1JG795YI) TEA TREE OIL (UNII: VIF565UC2G) OLIVE OIL (UNII: 6UYK2W1W1E) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Product Characteristics Color brown (Caramel) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0617-4 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/16/2019 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0617) , manufacture(58443-0617) , label(58443-0617) , analysis(58443-0617)
