Label: UNITED SPIRIT OF AMERICA (WARRIOR) BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0237-4 - 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 May 24, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
When using this product keep out of eyes. Rinse with water to remove.
- keep away from face to avoid breathing it.
- Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120 0F
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Directions
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- hold container 4 to 6 inches from the skin to apply
- do no 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
- Warrior Broad Spectrum SPF 30 Sunscreen Continuous Spray
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INGREDIENTS AND APPEARANCE
UNITED SPIRIT OF AMERICA (WARRIOR) BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 24.9 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 62.25 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 41.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 22.825 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 16.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOBORNYL ACETATE (UNII: 54T6CCU09Z) DIBUTYL MALEATE (UNII: 4X371TMK9K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALCOHOL (UNII: 3K9958V90M) VINYL ACETATE (UNII: L9MK238N77) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0237-4 177 mL in 1 CAN; Type 0: Not a Combination Product 08/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/14/2017 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0237) , analysis(13630-0237) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0237) , pack(13630-0237)