Label: CARAGALA - BOTANICAL DEFENSE DAY CREAM BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 8, 2022

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • ACTIVE INGREDIENTS

    Octinoxate 7.5%, Zinc Oxide 10.0%}

  • Purpose

    Sunscreen

  • USES

    Helps prevent sunburn.

  • 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 doctor if rash occurs.

    Keep out of each of children.

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

  • DIRECTIONS

    Apply to all skin exposed to the sun. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. If swimming or sweating, use water resistant sunscreen.

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Decrease this risk, by regularly using sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 am - 2 pm
    • wear long-sleeved shirts, pants, hats, and sunglasses

    Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENTS

    Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, VP/Eicosene Copolymer, Carthamus Tinctorius Oleosomes, Elettaria Cardamomum Seed Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Perilla Frutescens Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Santalum Album Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis Flower Extract, Cananga Odorata Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Cucumis Melo (Melon) Fruit Extract, Cucumis Sativus Fruit Extract, Jasminum Officinale Flower/Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rubus Idaeus (Raspberry) Fruit Extract, Polygonum Aviculare Extract, Vitis Vinifera Fruit Cell Extract, Propanediol, Cetearyl Alcohol, Pentylene Glycol, ArachidylAlcohol, PolyhydroxystearicAcid, Coco-Glucoside, HydroxyethylAcrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, PhenethylAlcohol, Caprylyl Glycol.

  • OTHER INFORMATION

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

  • PRINCIPAL DISPLAY PANEL - 60 G Tube Carton

    Cara Gala

    Botanical
    Defense
    Day Cream

    Broad Spectrum
    SPF 30
    Sunscreen

    SUNSCREEN

    NET WT. 2 OZ. (60G)

    PRINCIPAL DISPLAY PANEL - 60 G Tube Carton
  • INGREDIENTS AND APPEARANCE
    CARAGALA - BOTANICAL DEFENSE DAY CREAM BROAD SPECTRUM SPF 30 SUNSCREEN 
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-0302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Styrene/Acrylamide Copolymer (500000 MW) (UNII: 5Z4DPO246A)  
    Cocoyl Caprylocaprate (UNII: 8D9H4QU99H)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
    Cardamom (UNII: 8BC4CUT4JL)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Perilla Frutescens Seed (UNII: 8M62PUD356)  
    Apple (UNII: B423VGH5S9)  
    Santalum Album Seed (UNII: 7RZT0U509Y)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
    Cananga Odorata Flower (UNII: 76GTF6Z97M)  
    Orange Peel (UNII: TI9T76XD44)  
    Muskmelon (UNII: ZV095H5633)  
    Jasminum Officinale Flower (UNII: 0Q8K841432)  
    Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
    Raspberry (UNII: 4N14V5R27W)  
    Polygonum Aviculare Top (UNII: ZCD6009IUF)  
    Propanediol (UNII: 5965N8W85T)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Coco Glucoside (UNII: ICS790225B)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Docosanol (UNII: 9G1OE216XY)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    Phenylethyl Alcohol (UNII: ML9LGA7468)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-0302-11 in 1 CARTON04/01/2022
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/01/2022
    Labeler - Cosmetic Solutions LLC (807907928)
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