UNITED SPIRIT OF AMERICA BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

United Spirit of America by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 2.75%

Oxybenzone 2.0%

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 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 and 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-sleeve shirts, pants, hats and sunglasses
• Children under 6 months: ask a doctor

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carrageenan, Citric Acid, Diethylhexyl 2,6-Naphthalate, Disodium EDTA, Fragrance, Glyceryl Stearate, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyester-8, Polyethylene, Propylparaben, Sorbitol, Stearic Acid, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water

Other Information

Protect this product from excesive heat and direct sun

United Spirit of American Broad Spectrum SPF 30 Sunscreen

INGREDIENTS AND APPEARANCE

UNITED SPIRIT OF AMERICA  BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	19.2 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	19.2 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	72 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLPHTHALIDE (UNII: 822Q956KGM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CARRAGEENAN (UNII: 5C69YCD2YJ)
COCOA BUTTER (UNII: 512OYT1CRR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0189-3	85 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/11/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/04/2010

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0189) , manufacture(58443-0189) , label(58443-0189)