Label: HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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

  • Active ingredients

    TITANIUM DIOXIDE 14.2 %

    ZINC OXIDE 4.9 %

  • Purpose

    Sunscreen

  • Uses

    • Tinted compact SPF 50 helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions for use), decreases the risk if skin cancer and early skin aging caused by the sun.
  • 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 consult a health care practitioner

    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 use

    • Apply liberally/generously and evenly 15 minutes before sun exposure.
    • Reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours.
    • Children under 6 months: Consult a health care practitioner.
    • 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 of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. to 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses.

  • Inactive Ingredients

    DIMETHICONE, HYDROGENATED POLYISOBUTENE, PHENYL TRIMETHICONE, ISODECYL NEOPENTANOATE, SQUALANE, TALC, ETHYLHEXYL HYDROXYSTEARATE, SYNTHETIC WAX , POLYMETHYL METHACRYLATE, SILICA, WATER/EAU, POLYGLYCERLYL-3 DIISOSTEARATE, ALUMINA, STEARIC ACID, BEESWAX, CAPRYLIC/CAPRIC TRIGLYCERIDE, MICROCRYSTALLINE WAX, PHENOXYETHANOL, TOCOPHERYL GLUCOSIDE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, TITANIUM DIOXIDE (CI77891), IRON OXIDES (CI77492), (CI77491), (CI77499)

  • Other information

    Protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions ?

    1-866-41-AVENE

    (28363) (USA)

    1-877-441-2011 (CAN)

  • PACKAGE LABEL - HIGH PROTECTION TINTED COMPACT HONEY

    HAUTE PROTECTION

    HIGH PROTECTION

    COMPACT TEINTÉ – TINTED COMPACT

    DORE - HONEY and SABLE - BEIGE

    RÉSISTANT À L’EAU

    WATER RESISTANT

    40 minutes

    UVB UVA

    FPS



    SPF

    LARGE SPECTRE

    BROAD SPECTRUM

    50

    Peaux intolérantes – For intolerant skin

    NON COMÉDOGÉNE – N’OBSTRUE PAS LES PORES

    LABORATOIRES DERMATOLOGIQUES AVÈNE – PARIS

    10g e NET WT. 0.3 OZ.

    NPN 80085664

    Label

  • INGREDIENTS AND APPEARANCE
    HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66888-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.42 g  in 10 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.49 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROGENATED POLYISOBUTENE 8 (UNII: 7YR4ZFS62E)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    SQUALANE (UNII: GW89575KF9)  
    TALC (UNII: 7SEV7J4R1U)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TOCOPHERYL GLUCOSIDE (UNII: 9CKD1JE38R)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66888-051-011 in 1 CARTON03/16/2021
    110 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/16/2021
    Labeler - Tecnocosmesi S.p.A. (435445218)
    Registrant - Tecnocosmesi S.p.A. (435445218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tecnocosmesi S.p.A.435445218manufacture(66888-051)