Label: ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30- zinc oxide lotion

  • 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 November 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 15.7%

  • 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 a doctor if rash occurs.

    • Keep out of reach of children.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor.
    • Use daily or alone under makeup.

    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.
  • Other Information

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

    Aqua/Water/Eau, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Tetradecane, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Ectoin, Arachidyl Alcohol, Caprylyl Glycol, Diheptyl Succinate, Coco-Glucoside, Xanthan Gum, Calcium Sodium Borosilicate, Parfum (Fragrance)1, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Bisabolol2, Citric Acid, Arachidyl Glucoside, Sodium Gluconate, Glycerin, Caprylhydroxamic Acid, Tocopherol, Beta-Sitosterol, Squalene, Aloe Barbadensis Leaf Juice2, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Isomalt, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Malus Domestica Fruit Cell Culture Extract, Aronia Melanocarpa Fruit Extract2, Camellia Sinensis Leaf Extract2, Euterpe Oleracea Fruit Extract2, Lycium Barbarum Fruit Extract2, Spirulina Maxima Extract, sr-Hydrozoan Polypeptide-1, Lecithin, Sodium Benzoate, Vitis Vinifera (Grape) Fruit Cell Extract, Potassium Sorbate.

    1
    Natural Fragrance
    2
    Certified Organic,
  • Questions or Comments?

    Call (415) 446-9470.

  • SPL UNCLASSIFIED SECTION

    Dist. by Andalou Naturals,
    Petaluma, CA 94954.

  • PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

    MINERAL
    SUNSCREEN

    ANDALOU
    NATURALS

    DAILY SHADE +
    Blue Light Defense
    Facial Lotion
    Hyaluronic Acid + Ectoin

    Broad Spectrum
    SPF 30

    FRUIT
    STEM
    CELL
    SCIENCE®

    DEEP
    HYDRATION

    2.7 fl oz / 80 mL

    PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-2201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE157 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TETRADECANE (UNII: 03LY784Y58)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    ECTOINE (UNII: 7GXZ3858RY)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    SQUALENE (UNII: 7QWM220FJH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ISOMALT (UNII: S870P55O2W)  
    BEET (UNII: N487KM8COK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-2201-11 in 1 CARTON01/12/2022
    180 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/12/2022
    Labeler - Andalou naturals (011472720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555MANUFACTURE(55560-2201)
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