Label: AUSTRALIAN GOLD BOTANICAL BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 13630-0140-4
- Packager: Prime Packaging, 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 June 21, 2022
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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 onto face. Spray on hands then apply to face
- do not apply in windy conditions
- use in a well-ventilated area
- 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-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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Inactive ingredients
Eucalyptus Globulus (Eucalyptus) Leaf Extract, Fragrance (Parfum), Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Trimethoxybenzylidene Pentanedione, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water/Aqua/Eau
- Other information
- Questions or comments?
- Botanical Sunscreen 70 Broad Spectrum SPF 70 Natural Spray
-
INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BOTANICAL BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 86.1 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25.83 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 43.05 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 43.05 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) KAKADU PLUM (UNII: 0ZQ1D2FDLI) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) VINYL ACETATE (UNII: L9MK238N77) DIBUTYL MALEATE (UNII: 4X371TMK9K) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0140-4 177 mL in 1 CAN; Type 0: Not a Combination Product 10/02/2018 02/28/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/02/2018 02/28/2025 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0140) , analysis(13630-0140) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0140) , pack(13630-0140)
