Label: REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY- octinoxate, octisalate, and titanium dioxide cream

  • NDC Code(s): 49527-022-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Octisalate 3.5%
    Titanium dioxide 1.7%

  • 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

    water\aqua\eau • neopentyl glycol diheptanoate • simmondsia chinensis (jojoba) butter • glycerin • petrolatum • octyldodecyl neopentanoate • di-c12-15 alkyl fumarate • dimethicone • hydrogenated lecithin • butylene glycol • hydrogenated polyisobutene • hexyldecyl stearate • sigesbeckia orientalis (st. paul's wort) extract • whey protein\lactis protein\protéine du petit-lait • salvia sclarea (clary) extract • chlorella vulgaris extract • commiphora mukul resin extract • litchi chinensis seed extract • laminaria digitata extract • cladosiphon okamuranus extract • plankton extract • astrocaryum murumuru seed butter • acetyl hexapeptide-8 • lecithin • polyethylene • pentylene glycol • potato starch modified • ergothioneine • glyceryl stearate • caffeine • sorbitol • behenyl alcohol • sodium hyaluronate • methicone • tocopheryl acetate • peg-100 stearate • pentaerythrityl tetraethylhexanoate • caprylyl glycol • c12-16 alcohols • cholesterol • caprylic/capric triglyceride • polysilicone-11 • dextrin • palmitic acid • tetrahexyldecyl ascorbate • hexylene glycol • citric acid • xanthan gum • alumina • ammonium acryloyldimethyltaurate/vp copolymer • sodium hydroxide • disodium edta • potassium sorbate • phenoxyethanol • red 4 (ci 14700) • yellow 5 (ci 19140) • titanium dioxide (ci 77891) • mica [iln39272]

  • Other information

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

  • SPL UNCLASSIFIED SECTION

    DIST. N.Y., N.Y. 10022

  • PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

    C
    CLINIQUE

    repairwear uplifting

    firming cream
    broad spectrum SPF 15

    DRY COMBINATION TO COMBINATION OILY

    POIDS NET WT. 1.7. OZ./50 ml e

    Principal Display Panel - 50 mL Jar Carton
  • INGREDIENTS AND APPEARANCE
    REPAIRWEAR UPLIFTING FIRMING  BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY
    octinoxate, octisalate, and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE17 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    JOJOBA BUTTER (UNII: XIA46H803R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYLDECYL STEARATE (UNII: OJX2P28Y14)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    GUGGUL (UNII: 34969JX79R)  
    LITCHI CHINENSIS SEED (UNII: 9294024N9Q)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    CLADOSIPHON OKAMURANUS (UNII: 2IJE0CH09J)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SORBITOL (UNII: 506T60A25R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    C12-16 ALCOHOLS (UNII: S4827SZE3L)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-022-011 in 1 CARTON10/01/2012
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2012
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-022) , pack(49527-022) , label(49527-022)