Label: WARRIOR SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 58443-0388-3
- 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 14, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 two 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
Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Alumina, Aluminum Starch Octenylsuccinate, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Isotridecyl Isononanoate, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Sodium Chloride, Stearic Acid, Tocopheryl Acetate, Trimethylsiloxysilicate, Water
- Other Information
- Warrior Broad Spectrum SPF 50 Sunscreen Minerals Formula
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INGREDIENTS AND APPEARANCE
WARRIOR SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0388 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 41 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 41 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HEXYL LAURATE (UNII: 4CG9F9W01Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) DIMETHICONE (UNII: 92RU3N3Y1O) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Product Characteristics Color white (Off White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0388-3 88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/02/2020 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprise, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0388) , label(58443-0388) , analysis(58443-0388) , pack(58443-0388)
