MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER (OCTINOXATE, OXYBENZONE, AND ZINC OXIDE) CREAM [MAKEUP ART COSMETICS]

MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER (OCTINOXATE, OXYBENZONE, AND ZINC OXIDE) CREAM [MAKEUP ART COSMETICS]
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NDC 40046-0074-1
Set ID ed4ca733-dbff-4ee7-b6c5-1ccad7a0717b
Category HUMAN OTC DRUG LABEL
Packager MAKEUP ART COSMETICS
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.50%Sunscreen
    Zinc Oxide 4.00%Sunscreen
    Oxybenzone 2.50%Sunscreen
  • Use

    helps prevent sunburn

  • Warnings

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

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

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply every two hours
    • use a water resistant sunscreen if swimming or sweating
    • 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 of higher and other sun protection measures including:
      • limit 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
  • inactive ingredients

    water\aqua\eau, dimethicone, butylene glycol, butyrospermum parkii (shea butter), octyldodecyl neopentanoate, biosaccharide gum - 1, ascorbyl glucoside, sucrose, polyglyceryl-10 pentastearate, behenyl alcohol, tocopheryl acetate, sodium hyaluronate, squalane, gentiana lutea (gentian) root extract, hordeum vulgare (barley) extract\extrait d'orge, triticum vulgare (wheat) germ extract, hydrolyzed rice bran extract, algae extract, palmaria palmata extract, porphyra yezoensis (algae) extract, silk powder\serica\poudre de soie, caffeine, acetyl glucosamine, polyglyceryl-6 polyricinoleate, dipotassium glycyrrhizate, tourmaline, cholesterol, alumina, silica, polyethylene, sodium stearoyl lactylate, xanthan gum, tromethamine, caprylyl glycol, pentylene glycol, hexylene glycol, isopropyl titanium triisostearate, glyceryl stearate, peg-100 stearate, citric acid, stearic acid, fragrance (parfum), disodium edta, phenoxyethanol, sodium benzoate, chlorphenesin, mica, titanium dioxide (ci 77891) <iln41093>

  • Other information

    protect the product in this container from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

    DIST. BY/PAR: MAKE-UP ART COSMETICS
    TORONTO, ONTARIO, CANADA M5V 1R7,
    LONDON W1K 3BQ / MWGO

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    M•A•C
    LIGHTFUL
    C

    MARINE-BRIGHT FORMULA
    SPF 30
    MOISTURIZER
    BROAD SPECTRUM
    SPF 30

    50 ML/1.7 US FL OZ e

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER 
    octinoxate, oxybenzone, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08025 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02675 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0428 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    butylene glycol (UNII: 3XUS85K0RA)  
    shea butter (UNII: K49155WL9Y)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    biosaccharide gum-1 (UNII: BB4PU4V09H)  
    ascorbyl glucoside (UNII: 2V52R0NHXW)  
    sucrose (UNII: C151H8M554)  
    docosanol (UNII: 9G1OE216XY)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    squalane (UNII: GW89575KF9)  
    gentiana lutea root (UNII: S72O3284MS)  
    barley (UNII: 5PWM7YLI7R)  
    wheat germ (UNII: YR3G369F5A)  
    dulse (UNII: 7832HOY4ZQ)  
    porphyra yezoensis (UNII: D72A570T01)  
    caffeine (UNII: 3G6A5W338E)  
    n-acetylglucosamine (UNII: V956696549)  
    glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)  
    cholesterol (UNII: 97C5T2UQ7J)  
    aluminum oxide (UNII: LMI26O6933)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    high density polyethylene (UNII: UG00KM4WR7)  
    sodium stearoyl lactylate (UNII: IN99IT31LN)  
    xanthan gum (UNII: TTV12P4NEE)  
    tromethamine (UNII: 023C2WHX2V)  
    caprylyl glycol (UNII: 00YIU5438U)  
    pentylene glycol (UNII: 50C1307PZG)  
    hexylene glycol (UNII: KEH0A3F75J)  
    isopropyl titanium triisostearate (UNII: 949E3KBJ1I)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    peg-100 stearate (UNII: YD01N1999R)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    stearic acid (UNII: 4ELV7Z65AP)  
    edetate disodium (UNII: 7FLD91C86K)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    sodium benzoate (UNII: OJ245FE5EU)  
    chlorphenesin (UNII: I670DAL4SZ)  
    mica (UNII: V8A1AW0880)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0074-11 in 1 CARTON02/16/2015
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/16/2015
    Labeler - MAKEUP ART COSMETICS (010597206)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516RELABEL(40046-0074) , REPACK(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157RELABEL(40046-0074) , REPACK(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774RELABEL(40046-0074) , REPACK(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0074)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(40046-0074)

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