UNITED SPIRIT OF AMERICA (WARRIOR) BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

United Spirit of America (Warrior) by

Drug Labeling and Warnings

United Spirit of America (Warrior) by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120ºF.

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.

Flammable: Do not use near heat, flame or while smoking.

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 not spray directly into face. Spray on hands then apply to face do not apply in windy conditions use in a well-ventilated area reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 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-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

Inactive ingredients

Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer.

Other information

Protect this product from excessive heat and direct sun.

Avoid spraying on fabrics - could cause discoloration.

United Spirit of America Continuous Spray Sunscreen SPF50 Sport

INGREDIENTS AND APPEARANCE

UNITED SPIRIT OF AMERICA (WARRIOR)  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0196
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	85.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.7 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	42.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0196-4	182 mL in 1 CAN; Type 0: Not a Combination Product	01/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/28/2019

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0196) , analysis(13630-0196)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0196) , pack(13630-0196)