ZINC OXIDE, TITANIUM DIOXIDE CREAM [MATCHCO INC.]

ZINC OXIDE, TITANIUM DIOXIDE CREAM [MATCHCO INC.]
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NDC 70798-415-22
Set ID 32aa75a5-49b3-35ab-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager MATCHCo Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • STATEMENT OF IDENTITY SECTION

    Drug Facts

    Active ingredients Purpose

    Titanium Dioxide 4.0% Sunscreen

    Zinc Oxide 5.9% Sunscreen

  • INDICATIONS AND USAGE SECTION

    Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection

    Warnings

    For external use only

    Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

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

  • WARNINGS SECTION

    Warnings

    For external use only

    Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

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

  • OTHER SAFETY INFORMATION

    Other information

    protect the product in this container from excessive heat and direct sun

  • OTC - ACTIVE INGREDIENT SECTION

    Active ingredients Purpose

    Titanium Dioxide 4.9% Sunscreen

    Zinc Oxide 5.9% Sunscreen

  • OTC - STOP USE SECTION

    Stop use and ask doctor if rash occurs.

  • Principal Display Panel

    Dist. By.

    MATCHCo, Inc

    Santa Monica, CA 90401

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  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE, TITANIUM DIOXIDE 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70798-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NYLON-12 (UNII: 446U8J075B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70798-415-2230 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/11/2016
    Labeler - MATCHCo Inc. (079937374)
    Registrant - MATCHCo Inc. (079937374)
    Establishment
    NameAddressID/FEIBusiness Operations
    MATCHCo Inc.079937374manufacture(70798-415)

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