Warrior Broad Spectrum SPF 50 Sunscreen Minerals Formula

Warrior by

Drug Labeling and Warnings

Warrior by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc., Prime Enterprise, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARRIOR SPF 50- titanium dioxide, zinc oxide lotion 
Prime Enterprises, Inc.

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.

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Warrior Broad Spectrum SPF 50 Sunscreen Minerals Formula

Active Ingredients

Titanium Dioxide 4%

Zinc Oxide 4%

Purpose

Sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away

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

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

protect this product from excessive heat and direct sun

Warrior Broad Spectrum SPF 50 Sunscreen Minerals Formula

WARRIOR  SPF 50
titanium dioxide, zinc oxide lotion

Product 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)

Revised: 1/2021

Document Id: b8e39038-d68d-3c1a-e053-2a95a90ab922

34390-5

Set id: b8e3e528-b7cf-e4b7-e053-2995a90a4029

Version: 1

Effective Time: 20210114