Label: SOLAR PROTECTION FORMULA SPF 65 SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 27, 2012

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients:

    Octinoxate 6%

    Octocrylene 7%

    Oxybenzone 4%

    Titanium Dioxide 4%

    Zinc Oxide 5%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

    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.

    Stop use and ask a doctor if rash occurs.

    When using this product, keep out of eyes. Rinse with water to remove.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    SHAKE WELL BEFORE USING

  • Other Information:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant product if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor
    • 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 value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10:00 a.m.-2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Inactive Ingredients:

    Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, 5-Bromo-5-Nitro-1, 3-Dioxane, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Dimethicone, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Selenium Yeast Extract, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

    Solar Protection Formula combines Titanium Dioxide, Zinc Oxide, and Iron Oxide to form a complete wall of reflection against UVA/UVB damage.

    Manufactured exclusively for
    Fallien Ltd., West Norriton, PA
    Made in USA

  • Principal Display Panel – 2 oz Carton Label

    NDC 58892-265-59

    SOLAR

    PROTECTION

    FORMULA®

    Oil Free

    Non-comedogenic

    SPF 65

    Broad Spectrum

    UVA/UVB

    2 Fl. Oz. / 58.8ml

    Principal Display Panel – 2 oz Carton Label
  • INGREDIENTS AND APPEARANCE
    SOLAR PROTECTION FORMULA SPF 65   SUNSCREEN
    octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate60 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone40 mg  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    5-Bromo-5-Nitro-1,3-Dioxane (UNII: U184I9QBNM)  
    .Beta.-Carotene (UNII: 01YAE03M7J)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Isobutylparaben (UNII: 0QQJ25X58G)  
    Isopropylparaben (UNII: A6EOX47QK0)  
    Linoleamidopropyl Dimethylamine (UNII: W142CF4WLF)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Maritime Pine (UNII: 50JZ5Z98QY)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
    Talc (UNII: 7SEV7J4R1U)  
    Tocopherol (UNII: R0ZB2556P8)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-265-591 in 1 CARTON
    158.8 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2004
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE(58892-265)
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