Label: WHOLE BODY ORGANIC SUNSCREEN- 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 April 13, 2021

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  • Drug Facts

  • Active Ingredient:

    Non-Nano Uncoated Zinc Oxide 20%

  • Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Use: • ​Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the chance 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

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

  • DOSAGE & ADMINISTRATION

    ​Directions: •​ Apply generously (2mg /cm​2​ of skin) 15 minutes before sun exposure. • ​Reapply after 40 minutes of swimming or sweating, immediately after towel drying, atleast every 2 hours. ​• ​For Children under 6 months: ask a doctor.​ •​ ​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 15 or higher and other sun protection measures including: ​•​ limit time in the sun, especially from 10 a.m. - 2 p.m. ​•​ wear long- sleeve shirts, pants, hats and sunglasses.

  • INACTIVE INGREDIENT

    Inactive ​Ingredients: Simmondsia Chinensis (Jojoba) Seed Oil​*​, Helianthus Annuus (Sunflower) Seed Oil​*, Calendula Officinalis (Calendula) Flower Oil​*​, Cera Alba (Beeswax)​*​​,Copernicia Cerifera (Carnauba) Wax​*​, Butyrospermum Parkii (Shea Butter)​*​, Carthamus Tinctorius Seed Oil​ / Safflower Acid, Cocos Nucifera (Coconut) Oil​*​, Isoamyl Laurate​, Caprylic / Capric Triglycerides, Macadamia Integrifolia (Macadamia) Oil*​, Persea Gratissima (Avocado) Oil​*​, Theobroma Cacao (Cocoa) Butter​*​,  Rosa Damascena (Rose) Flower Extract, Calendula Officinalis (Flower) Extract​*​, Hippophae Rhamnoides (Seabuckthorn) Fruit Extract​*​, Oenothera Biennis (Evening Primrose) Oil​*​, Rosa Canina (Rosehip) Seed Oil​*​, Iron Oxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E), Pelargonium Graveolens (Geranium) Oil​*​, Lavandula Angustifolia (Lavender) Oil​*​, Cymbopogon Martini (Palmarosa) Oil​*​, Linalool​**​, Geraniol​**​, Citronellol​**​, Eugenol​**​

    ​*​ Certified Organic Ingredients        ** ​Naturally occurring in essential oils

  • STORAGE AND HANDLING

    ​Other information: •​ Store at temperatures between 70-90o​F/21-32​o​C. Higher or lower temperatures may cause the product to separate or thicken. • ​May stain some fabrics.

  • SPL UNCLASSIFIED SECTION

    95% Organic Natural Ingredients

    Water Resistant 40 minutes

    BROAD SPECTRUM SPF 30

    UVA/UVB

    SHEER TINT

    Certified Organic

    No harmful chemical ingredients

    Not Tested on Animals

    Manufactured by Alteya Organics LLC,

    Yagoda 6167, Made in Bulgaria. www.AlteyaOrganics.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    WHOLE BODY ORGANIC SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71330-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SAFFLOWER ACID (UNII: Y788KS82OV)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ROSA CANINA SEED (UNII: 4503R1M9UT)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71330-101-9090 mL in 1 TUBE; Type 0: Not a Combination Product04/01/201704/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/201704/30/2021
    Labeler - ALTEYA ORGANICS OOD (503572407)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALTEYA ORGANICS OOD503572407manufacture(71330-101)
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