Label: CHANTECAILLE JUST SKIN TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15 SHADE WHEAT- titanium dioxide cream

  • NDC Code(s): 42893-025-00
  • Packager: Chantecaille Beaute Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts

  • Active Ingredients

    TITANIUM DIOXIDE 10.622%

    Purpose

    SUNSCREEN

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of 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 ask doctor

    if rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 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
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • Do not use if carton is open or if seal underneath tube cap is missing or broken
  • Inactive Ingredients:

    WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, NEOPENTYL GLYCOL DIETHYLHEXANOATE, TALC, GLYCERIN, PEG-10 DIMETHICONE, DIMETHICONE, PHENYL TRIMETHICONE, PENTYLENE GLYCOL, MAGNESIUM SULFATE, PEG-400, ALUMINUM HYDROXIDE, STEARIC ACID, SILICA DIMETHYL SILYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, DEXTRIN PALMITATE, TOCOPHEROL, ALCOHOL, DAMASK ROSE (ROSA DAMASCENA) FLOWER WATER, EDELWEISS (LEONTOPODIUM ALPINUM) FLOWER/LEAF EXTRACT, THYMUS VULGARIS (THYME) FLOWER/LEAF EXTRACT, BUDDLEJA DAVIDII EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CHONDRUS  ELATUS/SACCHARINA ANGUSTATA/MONOSTROMA NITIDUM THALLUS EXTRACT, HONEYSUCKLE (LONICERA JAPONICA) FLOWER EXTRACT, SUPEROXIDE DISMUTASE, SODIUM DEXTRAN SULFATE, SOYBEAN (GLYCINE SOJA) PROTEIN, SODIUM BENZOATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, POTASSIUM SORBATE [+/-: MICA, IRON OXIDES (CI 77491/CI 77492/Cl 77499)]

  • Package Labeling:

    Outer Package8Inner Package8

  • INGREDIENTS AND APPEARANCE
    CHANTECAILLE JUST SKIN TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15 SHADE WHEAT 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42893-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE106.22 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALCOHOL (UNII: 3K9958V90M)  
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    LEONTOPODIUM NIVALE SUBSP. ALPINUM WHOLE FLOWERING (UNII: 7R4LQP52DM)  
    THYME (UNII: CW657OBU4N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42893-025-001 in 1 CARTON11/01/2020
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/2020
    Labeler - Chantecaille Beaute Inc (095270166)
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