Label: MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT- zinc oxide lotion

  • NDC Code(s): 68577-165-00
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients

    Zinc Oxide 12.0015%

  • PURPOSE

    Purpose

    Sunscreen

  • USES

    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 cause by the sun
  • WARNINGS

    Warnings

    For external use only

    Do not useon damaged or broken skin

    Stop use and ask a doctor if

    • rash or irritation develops and lasts

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

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

  • DIRECTIONS

    Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months of age: ask a doctor

    Sun Protection Measures

    Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Water (Aqua), Squalane, Isoamyl Laurate, Butyloctyl Salicylate, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-3 Diisostearate, Methylpropanediol, Isopropyl Isostearate, Niacinamide, Sodium Chloride, Polyglyceryl-6 Polyricinoleate, Silica, Sorbitan Sesquiisostearate, Caprae Lac (Goat Milk), Bifida Ferment Lysate, Milk Protein, Eryngium Alpinum (Blue Thistle) Flower Extract, Carthamus Tinctorius (Safflower) Seed Oil, Sambucus Nigra (Elderberry) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Hydroxyacetophenone, Mica, 1,2-Hexanediol, Caprylyl Glycol, Lauroyl Lysine, Glycerin, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Lactose May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

  • Primary Package- LIGHT

    PP_LIGHT

  • Secondary Package- LIGHT

    SP_DEEP

  • INGREDIENTS AND APPEARANCE
    MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.0015 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SQUALANE (UNII: GW89575KF9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    MILK PROTEIN (UNII: AY96EDV46J)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    ERYNGIUM ALPINUM FLOWER (UNII: D381NNL4PD)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    MICA (UNII: V8A1AW0880)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GOAT MILK (UNII: XE5K5I4RP7)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICA (UNII: ETJ7Z6XBU4)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    LACTOSE (UNII: J2B2A4N98G)  
    IRON OXIDES (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-165-001 in 1 CARTON01/01/2024
    130 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2024
    Labeler - COSMAX USA, CORPORATION (010990210)