Label: CHANTECAILLE JUST SKIN TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15 lotion

  • NDC Code(s): 42893-200-50
  • Packager: Chantecaille Beaute Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 24, 2023

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  • Active Ingredients

    Titanium Dioxide 10.622%

  • 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 a docor if rash occurs
    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 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

  • 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, ALUMINA,
    ALCOHOL DEN., DAMASK ROSE (ROSA DAMASCENA) FLOWER WATER, LEONTOPODIUM ALPINUM EXTRACT, THYMUS VULGARIS (THYME) FLOWER/LEAF EXTRACT, BUDDLEJA DAVIDII EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT,
    CHONDRUS ELATUS/SACCHARINA ANGUSTATA/MONOSTROMA NITIDUM THALLUS EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, SUPEROXIDE DISMUTASE, SODIUM DEXTRAN SULFATE, GLYCINE SOJA (SOYBEAN)
    PROTEIN, SODIUM BENZOATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, POTASSIUM SORBATE [+/-: TITANIUM DIOXIDE (Cl 77891), MICA, IRON OXIDES (CI 77491/CI 77492/Cl 77499)]

  • 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 the tube cap is missing or broken

  • Principal Dispplay Panel

    Image

  • INGREDIENTS AND APPEARANCE
    CHANTECAILLE JUST SKIN TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15 
    chantecaille just skin tinted moisturizer sunscreen broad spectrum spf 15 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42893-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10.622 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    ALUMINUM HYDRIDE (UNII: KZJ3T010RQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALCOHOL (UNII: 3K9958V90M)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    LEONTOPODIUM ALPINUM (UNII: 7R4LQP52DM)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    SUPEROXIDE DISMUTASE (CU-ZN) ACTIVE SITE (UNII: 9ZAR5FLK75)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MICA (UNII: V8A1AW0880)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42893-200-501 in 1 CARTON01/05/2021
    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 finalpart35201/05/2021
    Labeler - Chantecaille Beaute Inc. (095270166)
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