CALIFORNIA TAN SPF 45 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]

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  • CALIFORNIA TAN SPF 45 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]

CALIFORNIA TAN SPF 45 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]
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NDC 58443-0161-3
Set ID 40b92e12-8e18-4fd7-e054-00144ff88e88
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 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 2.75%

    Oxybenzone 2%

  • 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 and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and 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 INGREDIENT

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Pyruvic Acid, Saccharomyces Lysate Extract, Saccharomyces/Calcium Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water (Aqua)

  • Other Information

    • protect this product from excesive heat and direct sun
  • Questions or Comments?

    Call toll free 1-800-SUNCARE

  • California Tan SPF 45 Sunscreen Lotion

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    CALIFORNIA TAN  SPF 45 SUNSCREEN
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PYRUVIC ACID (UNII: 8558G7RUTR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0161-3133 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/11/2013
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0161) , manufacture(58443-0161) , label(58443-0161) , analysis(58443-0161)
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