Label: SUN SHIELD SPF 50- 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 December 15, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide - 8.6%

    Titanium Dioxide - 6.5%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    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

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes prior to 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in sun sun, especially from 10 am - 2 pm.
    • wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months: Ask a doctor.
  • INACTIVE INGREDIENT

    Water (Aqua), Cyclopenatasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Alminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Sodium Chloride, Polyglyceryl-4 Isostearate, Vitis Vinifera, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Tocopherol, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Isomalt, Dimethicone / Vinyl Dimethicone Crosspolymer Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Ascorbic Acid, Ascorbyl Palmitate, Citric Acid, Sodium Benzoate.

  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun.

  • QUESTIONS

    Call toll free 1-800 830-1491 in the USA.

    info@atzen.com

  • PRINCIPAL DISPLAY PANEL

    Toll free in USA: 800.830.1491

    Email: info@atzen.com

    www.atzen.com

    Developed in France. Made in USA.

    Sun Shield SPF 50

    Sun Shield SPF 50

  • INGREDIENTS AND APPEARANCE
    SUN SHIELD SPF 50 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE86 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    VITIS VINIFERA FRUIT RIND (UNII: 653OHN32Q1)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4161-21 in 1 CARTON12/15/2017
    1NDC:62742-4161-190 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/11/2017
    Labeler - ALLURE LABS INC (926831603)
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