Label: AUSTRALIAN GOLD SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0382-3 - Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 6, 2021
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
apply liberally 15 minutes before sun exposure
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, C12-15 Alkyl Benzoate, Glycerin, Polyethylene, Phenoxyethanol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Sodium Hydroxide, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Ethylhexylglycerin, Allantoin, Aloe Barbadensis Leaf Juice, Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract
- Other information
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- Australian Gold Ultimate Hydration Lotion Sunscreen SPF 30
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0382 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 51.45 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.87 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 77.175 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 51.45 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) POLYSORBATE 20 (UNII: 7T1F30V5YH) OLIVE OIL (UNII: 6UYK2W1W1E) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) COCOA BUTTER (UNII: 512OYT1CRR) TEA TREE OIL (UNII: VIF565UC2G) KAKADU PLUM (UNII: 0ZQ1D2FDLI) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SUNFLOWER OIL (UNII: 3W1JG795YI) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALOE VERA LEAF (UNII: ZY81Z83H0X) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ALLANTOIN (UNII: 344S277G0Z) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) Product Characteristics Color white (White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0382-3 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/23/2020 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0382) , label(58443-0382) , analysis(58443-0382) , pack(58443-0382)