Label: TINTED RADIANCE MOISTURIZER BROAD SPECTRUM SPF 32 MEDIUM TO TAN- zinc oxide and titanium dioxide cream

  • 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 June 23, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide - 6.0%

    Titanium Dioxide - 4.5%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures, decreases the risk of skin cancer and  early skin aging  caused by the sun.
  • WARNINGS AND PRECAUTIONS

    Warning:

    • For external use only.
  • DO NOT USE

    Do not use:

    • On damaged or broken skin.
  • WHEN USING

    When using this products:

    • Keep out of eyes.
    • Rinse with water to remove.
  • STOP USE

    Stop use and ask a doctor:

    • If rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    For Sunscreen use:

    • Apply liberally 15 minutes before sun exposer.
    • Use a water resistant sunscreen 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 increase your risk of skin cancer and early skin aging. To decrease the 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.
  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone Ployglyceryl-3, Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG -10/15 Crosspolymer, Stearic Acid, Aluminum Hydroxide, Sodium Chloride, Glycerin, Magnolia officinallis Bark Extract, Ectoin, Caprylyl Glycol, Teprenone, Sodium Hyaluronate, Vitis Vinifera, (Grape) seed extract, Tetrahexyldecyl Ascorbate, Ergothioneine, Tocopheryl Acetate, Tocopherol, Maltodextrin, Lecithin, Ethylhexyl Palmitate Caprylyc/Capric Triglyceride, PEG/PPG-18/18 Dimethicone, Polyglycerin-3 Crosspolymer, Hexyl Laurate, Cyclohexasiloxane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/Venyl Dimethicone Crosspolymer, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Silica Dimethyl Sylilate, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Butylene Glycol, Hexylene Glycol Fragrance, Mica, Silaca, May contains: Iron Oxide.

  • PRINCIPAL DISPLAY PANEL

    Dist. By.

    EVER LLC

    Sausalito, CA 94965

    IMG TRM Med-Tan.jpg

  • INGREDIENTS AND APPEARANCE
    TINTED RADIANCE MOISTURIZER BROAD SPECTRUM SPF 32 MEDIUM TO TAN 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4084
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    ECTOINE (UNII: 7GXZ3858RY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TEPRENONE (UNII: S8S8451A4O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4084-21 in 1 CARTON06/23/2017
    1NDC:62742-4084-130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/23/2017
    Labeler - Allure Labs Inc. (926831603)
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