ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM- 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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Ulta Self-tanning Sunscreen Lotion Broad Spectrum SPF 15 Light to Medium

Active ingredients

Avobenzone 2%, Octisalate 5%, and Octocrylene 2.5%

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, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other information

  • protect from excesive heat & direct sunlight

PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 177mL Tube Label

ULTA

TINTED

SELF-TANNING

SUNSCREEN LOTION

BROAD

SPECTRUM

SPF 15

LIGHT

MEDIUM

NON-GREASY FORMULA

INSTANT, HEALTHY GLOW

BRONZE

6 FL OZ (177mL)

ULTA  SPF 15 LIGHT MEDIUM BROAD SPECTRUM
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
2,6-DI-TERT-BUTYL-4-((METHYLTHIO)METHYL)PHENOL (UNII: 650986R470)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARAMEL (UNII: T9D99G2B1R)  
CETEARETH-22 (UNII: 28VZG1E234)  
DIHYDROXYACETONE (UNII: O10DDW6JOO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
L-ERYTHRULOSE (UNII: WKK1W5B83O)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0127-4177 mL in 1 TUBE; Type 0: Not a Combination Product01/01/200812/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/200812/31/2018
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0127) , pack(58443-0127) , manufacture(58443-0127) , analysis(58443-0127)

Revised: 4/2022
Document Id: dbd99833-cfc7-3e96-e053-2a95a90a56ba
Set id: 800910f0-4d44-48fc-af6b-7c5e6df0cf88
Version: 4
Effective Time: 20220404
 
Prime Enterprises, Inc.