UNITED SPIRIT SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion

United Spirit by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 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 am to 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, Ethyl Ferulate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Phenoxyethanol, Polyglyceryl-3 Distearate, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, VP/Acrylates/Lauryl Methacrylate Copolymer, Water

Other Information

protect this product from excessive heat and direct sun

Warrior No Trace Tinted Mineral Sunscreen Broad Spectrum SPF 50 Lotion

INGREDIENTS AND APPEARANCE

UNITED SPIRIT  SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0628
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	44.145 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	39.24 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LAURYL METHACRYLATE (UNII: B6L83074BZ)
ETHYL FERULATE (UNII: 5B8915UELW)
ALLANTOIN (UNII: 344S277G0Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
C13-15 ALKANE (UNII: 114P5I43UJ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	brown (Light Brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0628-3	88.7 mL in 1 TUBE; Type 0: Not a Combination Product	08/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/03/2023

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0628) , label(58443-0628) , analysis(58443-0628) , pack(58443-0628)