Label: CHANTECAILLE SEASCREEN 30 MINERAL BROAD-SPECTRUM SUNSCREEN MIST SPF 30- zinc oxide aerosol, spray

  • NDC Code(s): 42893-328-13
  • 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 February 6, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide - 15.2%

  • 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.

    Contents under pressure. Do not puncture or incinerate.

    Do note store at temperatures above 120 F.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product, keep out of eyes. Rinse with water to remove.

  • Directions

    Hold container 4 to 6 inches from the skin to apply

    Spay liberally and spread evenly by hand 15 minutes before sun exposure

    Do not spray directly into face. Spray on hands then apply to face

    Do not apply in windy conditions

    Use in a well-ventilated areas

    Reapply:

    -After 80 minutes of swimming or sweating

    -Immediately after towel drying

    -At least every 2 hours

    Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:

    -Limit time in the sun, especially from 10 a.m. – 2 p.m.

    -Wear long sleeves shirts, pants, hats, and sunglasses.

    Children under 6 months: ask a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact Poison Control Center right away.

  • Inactive Ingredients

    Citrus Aurantium Dulcis (Orange) Fruit Water, Water, Simmondsia Chinensis (Jojoba) Seed Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Methyl Dihydroabietate, Glycerin, Cetearyl Alcohol, Coco-Glucoside, Bentonite, Shea Butter Ethyl Esters, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Portulaca Oleracea Extract, Withania Somnifera Root Extract, Camellia Sinensis Leaf Extract, Fructose, Bisabolol, Ethyl Ferulate, Microcrystalline Cellulose, Cellulose Gum, Sodium Stearoyl Glutamate, Sodium Gluconate, Citric Acid, Caprylhydroxamic Acid, Caprylyl Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Citrus Nobilis (Mandarin Orange) Peel Oil

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions

    To report a serious adverse event contact Chantecaille Beaute, Inc. 584 Broadway No. 1111 New York NY 10012

  • Package Label

    SeaScreen SPF 30 Label

  • INGREDIENTS AND APPEARANCE
    CHANTECAILLE SEASCREEN 30 MINERAL BROAD-SPECTRUM SUNSCREEN MIST  SPF 30
    zinc oxide aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42893-328
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    PURSLANE (UNII: M6S840WXG5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ORANGE (UNII: 5EVU04N5QU)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY (UNII: IJ67X351P9)  
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    WATER (UNII: 059QF0KO0R)  
    MANDARIN OIL (UNII: NJO720F72R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42893-328-13177 mL in 1 CAN; Type 0: Not a Combination Product11/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02011/22/2021
    Labeler - Chantecaille Beaute Inc (095270166)
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