ULTA BROAD SPECTRUM SUNSCREEN SPF80- avobezone, enzulizole, 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 Broad Spectrum SPF 80 Sunscreen Lotion

Active Ingredients

Avobezone 3%, Ensulizole 1 %. Homosalate 15 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 4 %

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

  • apply liberally 15 minutes before sun exposure
  • reapply:

  • after 80 minutes of swimming or sweating. •  immediately after towel drying  •at least every 2 hour      

  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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 Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, c12-15 Alkyl Benzoate, Carrageenan, Citric Acid, Diethylhexyl 2,6-Naphthalate, Disodium EDTA, Glyceryl Stearate, Isopropylphthalimide, Methylisothiazolinone, Polyester-8, Polyethylene, 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 - 148 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 148 mL Tube Label


ULTA

DrY TOUCH

FACES SUNSCREEN

LOTION

BROAD

SPECTRUM

SPF 80

WATER RESISTANT (80 MINUTES)

LIGHTWEIGHT CLEAN FEEL

FAST ABSORBING

LEAVES SKIN SOFT + SMOOTH

SUNFACES

5FL. OZ. / 148 mL

ULTA  BROAD SPECTRUM SUNSCREEN SPF80
avobezone, enzulizole, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.2 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE9.4 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE141 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25.85 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE37.6 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)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIETHYL (6-CHLORO-2-CARBAZOLYL)METHYLMALONATE (UNII: 74I9HB1BX3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
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)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0130-4148 mL in 1 TUBE; Type 0: Not a Combination Product12/01/200812/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/200812/31/2018
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0130) , pack(58443-0130) , manufacture(58443-0130) , analysis(58443-0130)

Revised: 4/2022
Document Id: dbd9b52f-3144-dad1-e053-2a95a90a54f0
Set id: 2c9d911e-9084-471f-9c13-99d109b7b575
Version: 4
Effective Time: 20220404
 
Prime Enterprises, Inc.