Label: REDNESS SOLUTIONS MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY- octinoxate, titanium dioxide, and zinc oxide lotion

  • NDC Code(s): 49527-070-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 5.9%
    Titanium Dioxide 3.7%
    Zinc Oxide 2.9%

  • 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 • methyl trimethicone • phenyl trimethicone • dimethicone • triethylhexanoin • butylene glycol • trimethylsiloxysilicate • peg-10 dimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • aluminum hydroxide • c12-15 alkyl benzoate • lactobacillus ferment • citrus grandis (grapefruit) peel extract • magnolia grandiflora bark extract • poria cocos sclerotium extract • astrocaryum murumuru seed butter • glycerin • caffeine • sodium myristoyl sarcosinate • caprylyl methicone • methicone • polyglyceryl-6 polyricinoleate • disteardimonium hectorite • acetyl glucosamine • isopropyl titanium triisostearate • dimethicone crosspolymer-3 • lecithin • tocopheryl acetate • laureth-7 • dimethicone/peg-10/15 crosspolymer • sodium chloride • dipropylene glycol • disodium edta • polyaminopropyl biguanide • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] [iln37592]

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    CLINIQUE

    redness
    solutions

    makeup
    broad spectrum
    SPF 15
    with probiotic technology

    1 FL.OZ.LIQ./30 ml e

    PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    REDNESS SOLUTIONS MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY 
    octinoxate, titanium dioxide, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE59 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE37 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-070-011 in 1 CARTON12/01/2011
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2011
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-070) , pack(49527-070) , label(49527-070)