Label: AUSTRALIAN GOLD BOAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0071-4 - 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 January 17, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- PURPOSE
- Uses
- Warnings
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Directions
- apply liberally and spread evenly by hand 15 minutes before sun exposure
- hold container 4 to 6 inches from the skin to apply
- do not spray directly into face. Spray on hands then apply to face
- do not apply in windy conditions
- use in well-ventilated area
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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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
- Inactive Ingredients
- Other information
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BOAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25.1 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 62.7 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 41.8 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 22.9 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 16.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ALCOHOL (UNII: 3K9958V90M) FD&C RED NO. 40 (UNII: WZB9127XOA) DIBUTYL MALEATE (UNII: 4X371TMK9K) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) KAKADU PLUM (UNII: 0ZQ1D2FDLI) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color orange Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0071-4 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/06/2013 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0071) , pack(58443-0071) , manufacture(58443-0071) , analysis(58443-0071)
