CALIFORNIA TAN SPF 45 FACE SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) AEROSOL, FOAM [PRIME PACKAGING, INC.]

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  • CALIFORNIA TAN SPF 45 FACE SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) AEROSOL, FOAM [PRIME PACKAGING, INC.]

CALIFORNIA TAN SPF 45 FACE SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) AEROSOL, FOAM [PRIME PACKAGING, INC.]
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NDC 13630-0078-4
Set ID 09f29dfc-de81-40f1-ad17-56ee4efca509
Category HUMAN OTC DRUG LABEL
Packager Prime Packaging, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone 3 %, Homosalate 15%, Octisalate 5 %, and Octocrylene 2.75 %

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if use 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. Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

    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.

    Flammable Do not use near heat, flame or while smoking.

    Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

  • Directions

    • apply liberally and spread evenly by hand 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 a 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 Ingredients

    Acrylates/C12-22 Alkyl Methacrylate Cocolymer, Adenosine Cyclic Phesphate, Adenosine Triphosphate, Allantoin, Aloe Barbadensis Leaf Juice, Butane, Butylene Glycol, Camelllia Sinensis (Green Tea) Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recitita (Matricaria) Flower Extract, Coleus Forskohlii Root Extract, Disodium EDTA, EDTA, Glucose, Hydrolyzed Soy Protein, Isostearic Acid, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysorbate 20, Polysorbate 60, Propane, Propylene Glycol, Pyruvic Acid, Quaternium-15, Saccharomyces/Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Sodium Polyacrylate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

  • Other Information

    • protect this product from exessive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration

  • Questions or comments?

    Call toll free 1-800-SUNCARE

  • PRINCIPAL DISPLAY PANEL - 142 g Can Label

    PRINCIPAL DISPLAY PANEL - 142g Can Label

    California Tan

    CT

    45

    Face

    Mousse

    Sunscreen Mousse

    Broad Spectrum SPF 45

    Water Resistant

    (80 Minutes)

    OIL FREE • FRAGRANCE-FREE

    Net Wt. 5 oz (142g)

  • INGREDIENTS AND APPEARANCE
    CALIFORNIA TAN  SPF 45 FACE SUNSCREEN
    avobenzone, homosalate, octisalate, and octocrylene aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE300 g  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1500 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE500 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE275 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    CALCIUM (UNII: SY7Q814VUP)  
    MAGNESIUM (UNII: I38ZP9992A)  
    ZINC (UNII: J41CSQ7QDS)  
    COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO)  
    CATALASE (MICROCOCCUS LUTEUS) (UNII: 7TXA8K9WAE)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
    PYRUVIC ACID (UNII: 8558G7RUTR)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0078-4142 g in 1 CAN; Type 0: Not a Combination Product12/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/30/2013
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0078) , analysis(13630-0078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0078) , pack(13630-0078)
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