ULTA SUNSCREEN SPF 45- octinoxate, 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 SPF 45 Sunscreen Lotion

Active Ingredients

Octinoxate 7.5%, Octisalate 5 %, Octocrylene 8%, and Oxybenzone 6 %

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hour              
  • children under  6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Hydroxide, Butylphthalimide, Carrageenan, Citric Acid, Diazolidinyl Urea, Disodium EDTA, Glyceryl Stearate, Isopropyl Myristate, Isopropylphthalimide, Magnesium Aluminum Silicate, Methylparaben, Polyethylene, Propylparaben, Soluble Collagen, 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

Questions or Comments?:

 Call- 1-866-983-8582

PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label


ULTA

OIL-FREE

SUNSCREEN

LOTION

SPF

45

SUN

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

6 FL.OZ./177mL

ULTA  SUNSCREEN SPF 45
octinoxate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE71.25 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE76 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE57 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TETRAETHYLAMMONIUM HYDROXIDE (UNII: RA8VU41B1F)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0129-4177 mL in 1 TUBE; Type 0: Not a Combination Product03/12/200712/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/12/200712/31/2018
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0129) , pack(58443-0129) , manufacture(58443-0129) , analysis(58443-0129)

Revised: 4/2022
Document Id: dbd99e84-c8b0-36cd-e053-2a95a90ad7f9
Set id: 9c605e55-5148-4900-902b-f5ce1dbd7bd8
Version: 4
Effective Time: 20220404
 
Prime Enterprises, Inc.