Label: SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BEIGE) SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (HONEY) SUNSCREEN- octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BLUSH) 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 January 14, 2013

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients:

    Octinoxate 6%

    Octocrylene 7%

    Oxybenzone 4%

    Titanium Dioxide 10%

    Zinc Oxide 3.4%

  • 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, Caramel, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Methylparaben, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

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

    Solar Protection Formula offers the most complete protection from UVB/UVA available, and is essential for the medically light sensitive and for those concerned with the damaging effects of the sun.

  • Principal Display Panel – Beige Carton Label

    SOLAR

    PROTECTION

    FORMULA®

    TINTED
    CONCEALER

    SPF 60

    Broad Spectrum

    UVA/UVB

    2 Fl.Oz./59 ml

    Principal Display Panel – Beige Carton Label
  • Principal Display Panel – Honey Carton Label

    SOLAR

    PROTECTION

    FORMULA®

    TINTED
    CONCEALER

    SPF 60

    Broad Spectrum

    UVA/UVB

    2 Fl.Oz./59 ml

    Principal Display Panel – Honey Carton Label
  • Principal Display Panel – Blush Carton Label

    SOLAR

    PROTECTION

    FORMULA®

    TINTED
    CONCEALER

    SPF 60

    Broad Spectrum

    UVA/UVB

    2 Fl.Oz./59 ml

    Principal Display Panel – Blush Carton Label
  • INGREDIENTS AND APPEARANCE
    SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BEIGE)   SUNSCREEN
    octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-721
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate69 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene81 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone46 mg  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide115 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide39 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    .BETA.-Carotene (UNII: 01YAE03M7J)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Caramel (UNII: T9D99G2B1R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    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:58892-721-651 in 1 CARTON
    159 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/1994
    SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (HONEY)   SUNSCREEN
    octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-722
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate69 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene81 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone46 mg  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide115 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide39 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    .BETA.-Carotene (UNII: 01YAE03M7J)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Caramel (UNII: T9D99G2B1R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    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:58892-722-651 in 1 CARTON
    159 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/1994
    SOLAR PROTECTION FORMULA SPF 60 TINTED CONCEALER - (BLUSH)   SUNSCREEN
    octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-723
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate69 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene81 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone46 mg  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide115 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide39 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    .BETA.-Carotene (UNII: 01YAE03M7J)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Caramel (UNII: T9D99G2B1R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    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:58892-723-651 in 1 CARTON
    159 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/1994
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-721, 58892-722, 58892-723)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE(58892-721, 58892-722, 58892-723)
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