ULTA SPF 15 BROAD SPECTRUM LIGHT TO MEDIUM TINTED SUNLESS SUNSCREEN (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]

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  • ULTA SPF 15 BROAD SPECTRUM LIGHT TO MEDIUM TINTED SUNLESS SUNSCREEN (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]

ULTA SPF 15 BROAD SPECTRUM LIGHT TO MEDIUM TINTED SUNLESS SUNSCREEN (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0133-4
Set ID c26e3f30-e73c-4c3b-a5a6-c2b8492a52d4
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • 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:
    • at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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

    Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate,  Calendula Officinalis Flower Extract, Caramel, Ceteareth-20, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Dihydroxyacetone, Dimethicone, Disodium EDTA, Erythrulose, Fragrance (Parfum), Glycerin, Glyceryl Dilaurate, Isopropylphthalimide, Methylisothiazolinone, Phenoxyethanol, Polyethylene, Polyquaternium-37, PPG-1 Trideceth-6, Propylene Glycol, Propylene Glycol Dicaprylate/Dicaprate, Stearyl Alcohol, Tocopheryl Acetate, 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 15

    TINTED SUNLESS

    SUNSCREEN LOTION

    LIGHT to MEDIUM

    ULTA

    6 FL OZ (177mL)

  • INGREDIENTS AND APPEARANCE
    ULTA  SPF 15 BROAD SPECTRUM LIGHT TO MEDIUM TINTED SUNLESS SUNSCREEN
    avobenzone, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0133
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARAMEL (UNII: T9D99G2B1R)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    L-ERYTHRULOSE (UNII: WKK1W5B83O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0133-4118 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/26/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0133) , pack(58443-0133) , manufacture(58443-0133) , analysis(58443-0133)
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