Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, octocrylene, homosalate spray
- NDC Code(s): 58443-0611-4
- 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 3, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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
Water, Aloe Barbadensis Leaf Juice, Glycerin, Caramel,Phenoxyethanol, 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 Glutamate 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 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:58443-0611 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 49.6 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.7 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.6 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SODIUM CHLORIDE (UNII: 451W47IQ8X) 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) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARAMEL (UNII: T9D99G2B1R) DIMETHICONE (UNII: 92RU3N3Y1O) TEA TREE OIL (UNII: VIF565UC2G) FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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:58443-0611-4 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/26/2017 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0611) , manufacture(58443-0611) , label(58443-0611) , analysis(58443-0611)
