ULTA BEAUTY BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and 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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Ulta Beauty MAKEUP SETTING SPRAY SPF 50 Broad Spectrum Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

Purpose

Sunscreen

Uses

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

Alcohol Denat, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Benzyl Alcohol, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Cyclopentasiloxane, Dehydroacetic Acid, Fragrance, Glycerin, Polyester-8, Rosa Damascena Flower Water, Silica Silylate, Sodium Hyaluronate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other Information

Question or comments?

Call 1-866-983-8582

Ulta Beauty SPF 50 Broad Spectrum Sunscreen

Principal Display Label

ULTA BEAUTY  BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0323
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE46.45 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE37.16 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25.55 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27.87 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE92.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ALCOHOL (UNII: 3K9958V90M)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
MIDAMALINE HYDROCHLORIDE (UNII: 4CVP92LH8L)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
LEVOMENOL (UNII: 24WE03BX2T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0323-3100 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/04/2020
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0323) , manufacture(58443-0323) , label(58443-0323) , analysis(58443-0323)

Revised: 5/2020
Document Id: a5659844-d58a-6245-e053-2a95a90accae
Set id: a5659ea2-4e86-5fbc-e053-2a95a90a8856
Version: 1
Effective Time: 20200511
 
Prime Enterprises Inc.