Label: CAUDALIE DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

  • NDC Code(s): 76296-060-30, 76296-060-39, 76296-060-50
  • Packager: Caudalie USA, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 1, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredient Purpose

    Zinc Oxide 21.1% ...... 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

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

  • STOP USE

    Stop use and ask a doctor if • rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply generously and evenly 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, regulalry 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 singlasses.

    •Children under 6 months of age: Ask a doctor.

  • Other information

    • Protect the product in this contaner from excessive heat and direct sun.

  • Inactive ingredients

    Aqua/Water/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Erythritol, Lauryl Laurate, Propanediol, Carthamus Tinctorius Oleosomes, Bentonite, Niacinamide, Palmitoyl Grapevine Shoot Extract, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Helianthus Annuus (Sunflower) Seed Oil,Sucrose Stearate, Coco-Glucoside, Bisabolol, Citric Acid, Caramel, Polyhydroxystearic Acid, Pongamia Pinnata Seed Extract, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Tocopherol, Microcrystallnine Cellulose, Beta-Sitosterol, Gluconolactone, Squalene, Xanthan Gum, Aloe Barbadensis Leaf Juice Powder, Sodium Benzoate.

  • Questions?

    +1-866-826-1615

  • 30 mL Pack

    30 mL Outer Label_Page_130 mL Outer Label_Page_230 mL Inner Label

  • 50 mL Pack

    50 mL Outer Label50 mL Inner Label

  • Co-pack

    Copack Label

  • INGREDIENTS AND APPEARANCE
    CAUDALIE DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76296-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.1875 g  in 62.5 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARAMEL (UNII: T9D99G2B1R)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BOROSILICATE GLASS (UNII: BOJ6T9AR90)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ERYTHRITOL (UNII: RA96B954X6)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    BENTONITE (UNII: A3N5ZCN45C)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    SQUALENE (UNII: 7QWM220FJH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76296-060-301 in 1 CARTON05/20/2024
    137.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76296-060-501 in 1 CARTON05/20/2024
    262.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:76296-060-391 in 1 CARTON05/20/2024
    337.5 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/20/2024
    Labeler - Caudalie USA, Inc. (100064349)