Label: TINTED CLEAR ZINC SOLAR PROTECTION SPF 30- zinc oxide 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 4, 2017

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  • ACTIVE INGREDIENT

    Zinc Oxide 17.67%

  • DOSAGE & ADMINISTRATION

    Directions: Masasge onto skin with fingertips, and reapply as needed. Avoid eye area while applying.

    For external use only.

  • INACTIVE INGREDIENT

    Other Ingredients: Water (Aqua), Cyclopentasiloxane, Dimethcone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crossploymer, Polyglyceryl-3 polydimethylsiloxyethyl Dimethicone, Cyclomethicone, PEG/PPG-18/18 Dimethicone, Hexyl triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, C12-15 Alkul benzoate, Poluisobutene, Isododecane, Phenoxyethanol, Sodium Hyaluronate, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Mica, Aloe barbadensis Leaf extract, Camellia Sinensis Leaf extract, Olea Europaea (Olive) Leaf Extarct, Silica, Titanium Dioxide, Iron Oxides

  • PRINCIPAL DISPLAY PANEL

    Physicians Aesthetic

    Research, Inc.

    www.lucrece.com

    Tinted Clear Zn SPF 30 25

  • INGREDIENTS AND APPEARANCE
    TINTED CLEAR ZINC SOLAR PROTECTION SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION176.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MICA (UNII: V8A1AW0880)  
    ALOE (UNII: V5VD430YW9)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4112-171 g in 1 TUBE; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/04/2017
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4112)
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