Label: SUN ARMOR 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 November 29, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients: Zinc Oxide 8.6% and Titanium Dioxide 6.5%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses: To help protect the skin from harmful UVA and UVB rays. If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early aging as well as helps prevent sunburn.

  • WARNINGS

    Warnings: For external use only.

  • WHEN USING

    When using this product: Keep out of eyes. If contacts occurs, rinse with water. Discontinue use if irritation or redness occurs.

  • STOP USE

    Stop use and ask a doctor: If severe skin irritation develops.

  • 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

    Directions: Apply sunscreen in the AM to fingertips and gently massage into the skin. Reapply as needed.

  • INACTIVE INGREDIENT

    Inactive Ingredients: 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, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Tocopheryl Acetate, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Sodium Chondroitin Sulfate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Dimethicone / Vinyl Dimethicone Crosspolymer Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Sodium Hyaluronate, Ectoin, Cyclotetrapeptide-24 Aminocyclohexane Carboxylate, Palmitoyl Oligopepetide, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit Cell Extract,Polygonum Aviculare Extract, Isomalt, Sodium Benzoate, Alcohol, Lecithin, Carbomer, Polysorbate 20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Tocopherol, Ascorbic Acid, Ascorbyl Palmitate, Citric Acid.

  • PRINCIPAL DISPLAY PANEL

    Mnaufacture for Dermaquest Inc

    Hayward, CA 94544

    1272 GK, NL Made In USA 

    ImageSunArmorSPF50

    ImageSunArmorSPF50

  • INGREDIENTS AND APPEARANCE
    SUN ARMOR SPF 50 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4096
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE86 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    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)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    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)  
    ECTOINE (UNII: 7GXZ3858RY)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    WINE GRAPE (UNII: 3GOV20705G)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    ISOMALT (UNII: S870P55O2W)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALCOHOL (UNII: 3K9958V90M)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4096-21 in 1 CARTON12/01/2017
    1NDC:62742-4096-156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/29/2017
    Labeler - Allure Labs, Inc (926831603)
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