URBAN OUTFITTERS SUNSCREEN SHIMMER BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Urban Outfitters Sunscreen Shimmer Lotion 30 Broad Spectrum SPF 30

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 2%

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 a Poison Control Center right away.

Directions

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Isopropylphthalimide ,Mangifera Indica (Mango) Seed Butter, Mica, Phenoxyethanol, Polyester-8, Polyethylene, Polysorbate 20, Propylene Glycol, Silk Amino Acids, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Titanium Dioxide, Tocopheryl Acetate, Water

Other information

Questions or comments?

Call toll free 1-800-282-2200

Urban Outfitters Sunscreen Shimmer Lotion 30 Broad Spectrum SPF 30

Principal Display Label

URBAN OUTFITTERS  SUNSCREEN SHIMMER BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0259
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20.2 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.78 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALLANTOIN (UNII: 344S277G0Z)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CARBOMER 1342 (UNII: 809Y72KV36)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
MICA (UNII: V8A1AW0880)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (Off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0259-4177 mL in 1 TUBE; Type 0: Not a Combination Product03/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/02/2018
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0259) , manufacture(58443-0259) , label(58443-0259) , analysis(58443-0259)

Revised: 1/2020
Document Id: 9c5af21a-5a9e-bcda-e053-2995a90a6906
Set id: 6804515c-d582-1563-e053-2991aa0ad9dd
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.