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

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United Spirit of America Broad Spectrum SPF 30 Sunscreen

Active Ingredients

Avobenzone 2.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 2.75%

Oxybenzone 2.0%

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

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

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

Principal Display Label

UNITED SPIRIT OF AMERICA  BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0189
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.2 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.2 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE72 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0189-385 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/04/2010
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0189) , manufacture(58443-0189) , label(58443-0189)

Revised: 5/2024
Document Id: 177d877f-2184-da2a-e063-6394a90a68a1
Set id: 20d1ae33-e229-55ea-e054-00144ff88e88
Version: 4
Effective Time: 20240502
 
Prime Enterprises Inc.