ZINCLEAR SPF 30 TINTED (ZINC OXIDE) CREAM [ALLURE LABS INC.]

ZINCLEAR SPF 30 TINTED (ZINC OXIDE) CREAM [ALLURE LABS INC.]
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NDC 62742-4064-1, 62742-4064-2
Set ID 0a6ce431-7370-44ff-839c-6e42d3a5bc10
Category HUMAN OTC DRUG LABEL
Packager Allure Labs Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient:

    Zinc Oxide - 18.6%

  • PURPOSE

    Purpose:Sunscreen

  • INDICATIONS & USAGE

    Uses:

    To help protect the skin from harmful UVA and UVB Rays

  • WARNINGS

    Warnings:

    For External Use only

  • WHEN USING

    When using this product

    • Keep out of eyes. If contact 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
  • INDICATIONS & USAGE

    Directions

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


  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxytethyl Dimethicone, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl, Glycol, Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan Gum, Polyester-7, Neopentyl Glycol Diheptanoate, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycrrihizate, Arabidopsis THaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ZINCLEAR SPF 30 TINTED 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE186 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    TEPRENONE (UNII: S8S8451A4O)  
    DATE (UNII: H3O7QI5HY7)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4064-21 in 1 CARTON
    1NDC:62742-4064-156.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/22/2014
    Labeler - Allure Labs Inc. (926831603)

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