Label: AUSTRALIAN GOLD SPF 15- avobenzone, octisalate, octocrylene spray
- NDC Code(s): 58443-0643-4
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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
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 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
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Inactive Ingredients
Water, Aloe Barbadensis leaf Juice, Glycerin, Butylphthallmide, Caramel, Phenoxyethanol, Isopropylphthalimide, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, polysorbate 20, Trimethylsiloxysilicate, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamte Diacetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Sodium Hydroxide, propylene Glycol, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride
- Other information
- Questions or comments?
- Australian Gold Instant Bronzer Spray Gel Sunscreen SPF15
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD SPF 15
avobenzone, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0643 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20.02 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.05 g in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20.02 g in 1 mL Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TEA TREE OIL (UNII: VIF565UC2G) CARAMEL (UNII: T9D99G2B1R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM HYDROXIDE (UNII: 55X04QC32I) OLIVE OIL (UNII: 6UYK2W1W1E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM CHLORIDE (UNII: 451W47IQ8X) 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:58443-0643-4 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/13/2022 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0643) , label(58443-0643) , analysis(58443-0643) , pack(58443-0643)
