Label: REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION- octinoxate, octisalate, and titanium dioxide cream

  • NDC Code(s): 49527-049-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 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 • pentaerythrityl tetraethylhexanoate • hexyldecyl stearate • polyethylene • pentylene glycol • potato starch modified • citrus reticulata (tangerine) peel extract • saccharomyces lysate extract • polygonum cuspidatum root extract • algae extract • coffea robusta seed extract • astrocaryum murumuru seed butter • padina pavonica thallus extract • betula alba (birch) bark extract • creatine • adenosine phosphate • laurdimonium hydroxypropyl hydrolyzed soy protein • linoleic acid • hydrolyzed rice extract • hydroxyproline • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • sigesbeckia orientalis (st. paul's wort) extract • coleus barbatus extract • acetyl hexapeptide-8 • sodium dna • caffeine • cholesterol • ethylhexyl stearate • sorbitol • ethylhexyl palmitate • decarboxy carnosine hcl • phytosphingosine • propylene glycol dicaprate • tocopheryl acetate • peg-100 stearate • disodium nadh • caprylyl glycol • acrylates copolymer • c12-16 alcohols • polysilicone-11 • squalane • palmitic acid • trehalose • glyceryl stearate • sodium rna • dipalmitoyl hydroxyproline • proline • citric acid • potassium sorbate • aminopropyl ascorbyl phosphate • behenyl alcohol • methicone • ammonium acryloyldimethyltaurate/vp copolymer • hexylene glycol • xanthan gum • sodium hydroxide • sodium hyaluronate • aluminum hydroxide • potassium sulfate • glycine • lecithin • carbomer • disodium edta • phenoxyethanol [iln41738]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    de-aging

    C
    CLINIQUE

    repairwear laser focus

    line smoothing cream
    broad spectrum SPF 15

    VERY DRY TO DRY COMBINATION

    POIDS NET WT. 1.7 OZ./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION 
    octinoxate, octisalate, and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.076125 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.03745 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.015225 g  in 100 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)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    HEXYLDECYL STEARATE (UNII: OJX2P28Y14)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TANGERINE PEEL (UNII: JU3D414057)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
    ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    PADINA PAVONICA (UNII: 177U06NHZI)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    CREATINE (UNII: MU72812GK0)  
    ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    WHEAT GERM (UNII: YR3G369F5A)  
    BARLEY (UNII: 5PWM7YLI7R)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    SORBITOL (UNII: 506T60A25R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DISODIUM NICOTINAMIDE ADENINE DINUCLEOTIDE (UNII: 8295030YNC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    C12-16 ALCOHOLS (UNII: S4827SZE3L)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SQUALANE (UNII: GW89575KF9)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TREHALOSE (UNII: B8WCK70T7I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POTASSIUM SULFATE (UNII: 1K573LC5TV)  
    GLYCINE (UNII: TE7660XO1C)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-049-011 in 1 CARTON10/01/2015
    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 DrugM02010/01/2015
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-049) , pack(49527-049) , label(49527-049)