Warrior Broad Spectrum SPF 50 Mineral Sunscreen Lotion

Warrior by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARRIOR BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion 
Prime Enterprises

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Warrior Broad Spectrum SPF 50 Mineral Sunscreen Lotion

Active Ingredients

Titanium Dioxide 4.5%

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 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 am - 2 pm
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: ask a doctor

Inactive Ingredients

Acrylic Acid/VP Crosspolymer, Allantoin, Aluminum Hydroxide, C12-15 Alkyl Benzoate, C13-15 Alkane, Camellia Oleifera (Green Tea) Leaf Extract, Caprylyl Glycol, Ceteareth-20, Cetyl Alcohol, Glycerin, Isododecane, Isohexadecane, Phenoxyethanol, Polyglyceryl-3 Distearate, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, VP/Acrylates/Lauryl Methacrylate Copolymer, Water

Other Information

protect this product from excessive heat and direct sun

Warrior Broad Spectrum SPF 50 Mineral Sunscreen Lotion

WARRIOR  BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0647
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	41.8 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	47.025 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C13-15 ALKANE (UNII: 114P5I43UJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ACRYLIC ACID (UNII: J94PBK7X8S)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURYL METHACRYLATE (UNII: B6L83074BZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0647-3	88.7 mL in 1 TUBE; Type 0: Not a Combination Product	05/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/02/2024

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	label(58443-0647) , manufacture(58443-0647) , analysis(58443-0647) , pack(58443-0647)

Revised: 5/2024

Document Id: 177bac90-e16b-42b3-e063-6394a90a7c97

34390-5

Set id: 177bac90-e16a-42b3-e063-6394a90a7c97

Version: 1

Effective Time: 20240502