Label: ALMOST POWDER MAKEUP BROAD SPECTRUM SPF 18- octinoxate and titanium dioxide powder

  • NDC Code(s): 49527-060-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 2.0%
    Titanium Dioxide 1.2%

  • 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 sunscreen 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 sunscreen 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

    talc•dimethicone•nylon-12•silica•squalane•boron nitride•vinyl dimethicone/methicone silsesquioxane crosspolymer•cetyl ethylhexanoate•diisostearyl malate•phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate•methicone•glycerin•sodium hyaluronate•magnesium palmitoyl glutamate•sodium palmitoyl sarcosinate•palmitoyl proline•alumina•tocopherol•palmitic acid•1,2-hexanediol•hydrated silica•ascorbyl tetraisopalmitate•aluminum hydroxide•tin oxide•sodium dehydroacetate•[+/- mica•iron oxides (ci 77491)•iron oxides (ci 77492)•iron oxides (ci 77499)•titanium dioxide (ci 77891)] [iln45192]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 10 g Jar Carton

    02 neutral fair (VF/MF)

    CLINIQUE

    almost powder makeup
    broad spectrum
    SPF 18

    POIDS NET WT. .35 OZ./10 g e

    PRINCIPAL DISPLAY PANEL - 10 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    ALMOST POWDER MAKEUP BROAD SPECTRUM SPF 18 
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SQUALANE (UNII: GW89575KF9)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)  
    SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)  
    PALMITOYL PROLINE (UNII: I49727TDYF)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-060-011 in 1 CARTON03/01/2018
    110 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2018
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASANUMA CORPORATION715464942manufacture(49527-060)