Label: BE BEAUTIFUL PURE MAKE UP BASE PURPLE- octinoxate, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 70618-008-01, 70618-008-02
  • Packager: THANK YOU FARMER CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 1, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Octinoxate 6.00% …………………………………Sunscreen
    Titanium Dioxide 4.02% ..………………..……Sunscreen
    Octisalate 2.00% ……………………....…………Sunscreen
    Zinc Oxide 1.92% ………………………………….Sunscreen

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  • PURPOSE

    Sunscreen

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  • INDICATIONS & USAGE

    Helps prevent sunburn

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  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

    Ask a doctor to use for children under 6 months

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  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    Stop using and ask a doctor if rash occurs

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

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INACTIVE INGREDIENT

    WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, PHENYL TRIMETHICONE, ISOEICOSANE, CAPRYLYL METHICONE, PEG-10 DIMETHICONE, DIMETHICONE, NIACINAMIDE, ULTRAMARINES (CI 77007), DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, DIMETHICONE CROSSPOLYMER, TALC, C12-14 PARETH-3, PHENOXYETHANOL, FRAGRANCE, PALMITIC ACID, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHICONE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, OCTYLDODECANOL, ADENOSINE, SODIUM HYALURONATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL

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  • INGREDIENTS AND APPEARANCE
    BE BEAUTIFUL PURE MAKE UP BASE PURPLE 
    octinoxate, homosalate, octisalate, octocrylene cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70618-008
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.4 mg  in 40 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.608 mg  in 40 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.8 mg  in 40 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.768 mg  in 40 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    TALC (UNII: 7SEV7J4R1U)  
    C12-14 PARETH-3 (UNII: 93RY22U87E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ADENOSINE (UNII: K72T3FS567)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70618-008-02 1 in 1 CARTON 11/01/2018
    1 NDC:70618-008-01 40 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/01/2018
    Labeler - THANK YOU FARMER CO., LTD. (689605142)
    Registrant - THANK YOU FARMER CO., LTD. (689605142)
    Establishment
    Name Address ID/FEI Business Operations
    Kolmar Korea Co., Ltd. 689512611 manufacture(70618-008)
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