Label: CALIFORNIA TAN BROAD SPECTRUM SPF 45- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 17, 2020

If you are a consumer or patient please visit this version.

  • Active ingredients

    Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %

  • PURPOSE

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

  • Other information

    • protect this product from excesive heat and direct sun

  • QUESTIONS

    Questions or Comments?

    Call toll free 1-800-SUNCARE

  • PRINCIPAL DISPLAY PANEL - 133 mL  Tube Label

    PRINCIPAL DISPLAY PANEL - 133 mL Tube Label

    CALIFORNIA TAN

    CT

    45

    SUNSCREEN LOTION

    Broad Spectrum SPF 45

    Water Resistant

    (80 Minutes)

    CLEANTOUCH

    TECHNOLOGY

    133 mL / 4.5 Fl Oz

  • INGREDIENTS AND APPEARANCE
    CALIFORNIA TAN  BROAD SPECTRUM SPF 45
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.9 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99.8 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.9 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PYRUVIC ACID (UNII: 8558G7RUTR)  
    CALCIUM (UNII: SY7Q814VUP)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    MAGNESIUM (UNII: I38ZP9992A)  
    ZINC (UNII: J41CSQ7QDS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STYRENE (UNII: 44LJ2U959V)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0097-3133 mL in 1 TUBE; Type 0: Not a Combination Product04/04/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/04/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0097) , pack(58443-0097) , manufacture(58443-0097) , analysis(58443-0097)