CALIFORNIA TAN CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING INC.]

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  • CALIFORNIA TAN CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING INC.]

CALIFORNIA TAN CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING INC.]
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NDC 13630-0112-4
Set ID 37867c19-8fd2-337e-e054-00144ff88e88
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 2%

    Homosalate 7.5%

    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. Keep away from face to avoid breathing it

    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.

  • Directions

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face
    • do not apply in windy conditions
    • use in a well-ventilated area
    • reapply:
    • after 80 minutes of swimming and 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 INGREDIENT

    Adenosine Cyclic Phosphate, Adenosine Triphosphate, Camellia Sinensis (Green Tea) Leaf Extract, Coleus Forskohlii Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Lycium Barbarum (Goji Berry) Fruit Extract, Micrococcus Lysate, Phospholipids, Plant Amino Acids, Polyester-8, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Alcohol Denat., VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)

  • Other Information

    • protect this product from excessive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration
  • Question or comments?

    Call toll free 1-800 SUNCARE

  • California Tan Contiuous Sunscreen Broad Spectrum SPF 30

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    CALIFORNIA TAN  CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE62 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.3 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.7 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    ALCOHOL (UNII: 3K9958V90M)  
    ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)  
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    WATER (UNII: 059QF0KO0R)  
    PYRUVIC ACID (UNII: 8558G7RUTR)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0112-4150 mL in 1 CAN; Type 0: Not a Combination Product12/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/30/2015
    Labeler - Prime Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(13630-0112) , analysis(13630-0112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059pack(13630-0112) , label(13630-0112)
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