ULTA SPF 20 BROAD SPECTRUM WATER RESISTANT SUNSCREN WITH SHIMMER- avobenzone, octisalate, and octocrylene 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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BronzeGlow Broad Spectrum SPF 20 Water Resistant Sunscreen Lotion with Shimmer

Active ingredients

Avobenzone 2%, Octisalate 5%, and Octocrylene 1.85%

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 hours
  • 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, Butylphthalimide, C12-15 Alkyl Benzoate,  Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methycellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Mica, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Titanium Dioxide, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call 1-866-983-8582

PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 177mL Tube Label

BRONZE GLOW

BROAD

SPECTRUM

SPF 20

WATER RESISTANT

(80 MINUTES)

SUNSCREEN LOTION

WITH SHIMMER

ULTA

6 FL OZ (177mL)

ULTA  SPF 20 BROAD SPECTRUM WATER RESISTANT SUNSCREN WITH SHIMMER
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE18.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARAMEL (UNII: T9D99G2B1R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0134-4177 mL in 1 TUBE; Type 0: Not a Combination Product09/20/201212/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/20/201212/31/2018
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0134) , pack(58443-0134) , manufacture(58443-0134) , analysis(58443-0134)

Revised: 4/2022
Document Id: dbda03c7-0479-39b9-e053-2995a90a53ee
Set id: fb7d612b-286d-4d67-95e1-c4d34598971a
Version: 4
Effective Time: 20220404
 
Prime Enterprises, Inc.