Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, octocrylene, homosalate spray
- NDC Code(s): 58443-0570-4
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 3, 2024
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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 ine 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 protecion measures including:
- limit time in the sun, especially from 10am-2pm
- wear long sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Caramel, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Trimethylsiloxysilicate, Water
- Other Information
- Questions or Comments?
- Australian Gold INSTANT BRONZER Broad Spectrum SPF 50
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN
octisalate, avobenzone, octocrylene, homosalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0570 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 49.5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.7 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 (UNII: 7T1F30V5YH) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYPROMELLOSES (UNII: 3NXW29V3WO) OLIVE OIL (UNII: 6UYK2W1W1E) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) KAKADU PLUM (UNII: 0ZQ1D2FDLI) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARAMEL (UNII: T9D99G2B1R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) TEA TREE OIL (UNII: VIF565UC2G) FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 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:58443-0570-4 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/26/2021 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0570) , manufacture(58443-0570) , label(58443-0570) , analysis(58443-0570)