SAHI COSMETICS (SAHI COSMETICS SKIN PERFECTING ELIXIR FOUNDATION) LOTION [SAHI COSMETICS L.L.C.]

SAHI COSMETICS (SAHI COSMETICS SKIN PERFECTING ELIXIR FOUNDATION) LOTION [SAHI COSMETICS L.L.C.]
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NDC 72878-2530-1
Set ID 7d67400a-7352-4db9-e053-2a91aa0ae85b
Category HUMAN OTC DRUG LABEL
Packager SAHI Cosmetics L.L.C.
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

    Drug Facts Active Ingredients.

    Purpose

    Drug Facts (continued) 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 and other sun protection measures including:

    Octocrylene 2.5% Sunscreen
    Ethyl Methoxycinnamate 2.5%

    (octinoxate) Sunscreen
    Use helps prevent sunburn

    Warnings

    For external use only

    Limit time in the sun, especially from 10 a.m. – 2 p.m.

    Wear long-sleeved shirts, pants, hats, and sunglasses

    Do not use

    Children under 6 months of age: askadoctor.

    on damaged or broken

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

    Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases

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

    Directions

    For sunscreen use:
    apply liberally 15 minutes before sun

    skin

    exposure.
    reapply every two hours
    use a water resistant sunscreen if swimming or sweating.

    Inactive Ingredients

    DEIONIZED WATER, ALCOHOL,
    P O L Y M E T H Y L S I L S E S Q UI O X A N E ,
    T RIMET HYLSILOXYSILIC A TE, CYCLOPENT ASILOXANE, DIMETHICONE,GLYCERINE, STEARYL DIMETHICONE (AND) OCT ADECENE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY) SILYLETHYL DIMETHICONE, TOCOPHERYL ACET ATE, ISOSTEARYL ALCOHOL/CERAMIDE NP, ALOE BARBARDENSIS LEAF EXTRACT COCO NUCIFERA (COCONUT) OIL, SORBIT AN SESQUIOLEATE , VINYL DIMETHICONE CROSSPOLYMER, P O L Y M E T H Y L S I L S E S Q UI O X A N E , SILICA, MICA, ZINC, TIT ANIUM DIOXIDECI77891,IRONOXIDE CI 77491,IRONOXIDE CI77492,IRON OXIDE CI77499,MAGNESIUM SULFATE, PHENOXYETHANOL, CHLORPHENESIN, GLYCERIN, PALMITOYL HEXAPEPTIDE-12, PARFUM

    Other Information

    Protect the product in this container from excessive hear and direct sun.

    Drug Facts

    Dosage and Administration Section

    dosage and admin

    OTC-Active ingredient section

    OTC-Active ingredient section

    warning section

    warning

    OTC-Purpose

    OTC-Purpose

    OTC- Keep out of reach of children

    OTC- Keep out of reach of children

    Indications and Usage section

    indications and usage

    Inactive Ingredients Section

    Inactive Ingredients

  • INGREDIENTS AND APPEARANCE
    SAHI COSMETICS 
    sahi cosmetics skin perfecting elixir foundation lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72878-2530
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 0.025 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 0.025 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 g  in 0.025 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72878-2530-11 in 1 BOX03/01/2019
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2019
    Labeler - SAHI Cosmetics L.L.C. (070199057)
    Registrant - SAHI Cosmetics L.L.C. (070199057)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAHI Cosmetics LLC070199057manufacture(72878-2530)

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