Label: SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide lotion

  • NDC Code(s): 64141-025-01, 64141-025-02
  • Packager: Bobbi Brown Professional Cosmetics Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 3.0%
    Titanium Dioxide 1.6%

  • Purpose

    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 suncreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least 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 suncreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    water\aqua\eau • dimethicone • trimethylsiloxysilicate • cetyl peg/ppg-10/1 dimethicone • butylene glycol • glycerin • disteardimonium hectorite • polyglyceryl-3 diisostearate • sodium chloride • laminaria saccharina extract • butyrospermum parkii (shea butter) • fragrance (parfum) • ascorbyl palmitate • tocopherol • dimethicone crosspolymer • methicone • stearic acid • tocopheryl acetate • glyceryl oleate • lecithin • glyceryl stearate • citric acid • aluminum hydroxide • talc • disodium edta • linalool • sodium dehydroacetate • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln44078>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    BOBBI
    BROWN

    Skin Long-Wear Weightless
    Foundation
    Broad Spectrum SPF 15

    Full Cover
    Oil-Free Shine Control

    1 FL. OZ./30 ml e

    PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE16 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TALC (UNII: 7SEV7J4R1U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64141-025-011 in 1 CARTON07/21/2017
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:64141-025-021 in 1 CARTON12/22/2022
    213 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/21/2017
    Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(64141-025) , pack(64141-025) , label(64141-025)