Label: CLEARLY ZINQ TINTED HYDRATING FACIAL SPF GROWTH FACTOR 35- zinc oxide cream

  • NDC Code(s): 62742-4259-1, 62742-4259-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 4, 2024

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  • ACTIVE INGREDIENT

    Active ingredients:

    Zinc Oxide 20.28%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings: For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions •Apply generously and evenly15 minutes before 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher time in the sun, especially from 10 a.m. -2 p.m., •wear long-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.

  • OTHER SAFETY INFORMATION

    Other information • protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Isododecane, Polysilicone-11, C13-15 Alkane, Butyloctyl Salicylate, Propanediol Dicaprylate/Caprate, Dimethicone, Polyhydroxystearic Acid, Castor oil/IPDI Copolymer, Dilinoleic Acid/Butanediol Copolymer, Disodium Stearoyl Glutamate, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Lecithin, Coco-Caprylate/Caprate, Camellia Oleifera (Seed) Oil, Kinetin, Prunus Armeniaca (Apricot) Kernel Oil, Squalane,Aloe Barbadensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Hydrated Silica, Tocopheryl Acetate, May Contain +/-, CI 77491 (Iron Oxide), CI 77492 (Iron Oxide), CI 77499 (Iron Oxide)

  • PRINCIPAL DISPLAY PANEL

    Clearly ZinqTinted Hydrating Facial SPF GF 35

  • INGREDIENTS AND APPEARANCE
    CLEARLY ZINQ TINTED HYDRATING FACIAL SPF GROWTH FACTOR 35 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.28 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISODODECANE (UNII: A8289P68Y2)  
    KINETIN (UNII: P39Y9652YJ)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    SQUALANE (UNII: GW89575KF9)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4259-21 in 1 CARTON04/04/2024
    1NDC:62742-4259-148 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/04/2024
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4259)