Label: EVEREDEN SPF50 PREMIUM MINERAL SUNSCREEN- zinc oxide, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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  • STATEMENT OF IDENTITY

    Primary

  • ACTIVE INGREDIENT

    Titanium Dioxide 3.7%, Zinc Oxide 14%

  • 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.
    Stop use and ask a doctor if rash occurs.
    When using this product keep out of eyes. Rinse with water to remove.

  • WARNINGS

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

  • DIRECTIONS

    • Shake well before use
    • Apply liberally 15 minutes before sun exposure and
    as needed.
    • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months of age: 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 value of 15 or higher and other sun protection measures including:

    • Limit your time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.

  • INACTIVE INGREDIENTS

    Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Ether, C13-15 Alkane, Propanediol, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Stearyl Citrate, Trioctyldodecyl Citrate, Tocopheryl Acetate, Sorbitan Sesquioleate, Polyglyceryl-10 Mono/Dioleate, Silica, Polyhydroxystearic Acid, Carthamus Tinctorius (Safflower) Oleosomes, Stearic Acid, Aluminum Hydroxide, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Cucumis Sativus (Cucumber) Fruit Extract, Caesalpinia Spinosa Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Vitis Vinifera (Grape) Seed Oil, Rosa Rubiginosa Seed Oil, Pongamia Pinnata Seed Extract, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Bisbolol, Sodium Phytate, Phenylpropanol, Caprylyl Glycol

  • PRINCIPAL DISPLAY PANEL

    Secondary

  • INGREDIENTS AND APPEARANCE
    EVEREDEN SPF50 PREMIUM MINERAL SUNSCREEN 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72113-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    MONOSTEARYL CITRATE (UNII: YWW937R1QR)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72113-107-141 in 1 CARTON01/18/2022
    160 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/18/2022
    Labeler - Eden Brands Inc (081062339)
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