Label: ETERNAL SPIRIT BEAUTY SPF 50SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

  • NDC Code(s): 58443-0339-3
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL

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 June 19, 2020

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  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 2.75%

    Oxybenzone 4%

  • 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. Keep away from face to avoid breathing it.

    Stop use and ask a doctor if rash occurs

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

    Flammable: Do not use near heat, flame or while smoking.

  • Directions:

    • shake well
    • close eyes completely. Mist over face evenly, holding bottle 10-12 inches away from face. Do not breathe mist in. Wait until dry.
    • apply liberally and evenly 15 minutes before sun exposure.
    • do not apply in windy conditions.
    • use in a well ventilated area
    • reapply:
    • after 80 minutes of swimming or sweating
    • inmediately after towel drying
    • at least every 2 hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive ingredients:

    SD Alcohol 40-B, Cyclopentasiloxane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water, Silica Silylate, Rosa Damascena Flower Water, Mentha Viridis (Spearmint) Leaf Oil, Bisabolol, Polyester-8, Tocopheryl Acetate, Ascorbyl Palmitate, Glycerin, Camellia Oleifera (Green Tea) Leaf Extract, Benzyl Alcohol, Aloe Barbadensis Leaf Juice Powder, Dehydroacetic Acid, Sodium Hyaluronate.

  • Other Information:

    • protect this product from excessive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration
  • Question or comments?

    Call 1-866-983-8582

  • Eteral Spirit Beauty Sunscreen Spray SPF 50

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    ETERNAL SPIRIT BEAUTY  SPF 50SUNSCREEN
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0339
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.4 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE24.2 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE35.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    WATER (UNII: 059QF0KO0R)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    ALCOHOL (UNII: 3K9958V90M)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Coloryellow (Very light yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0339-3118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/11/2018
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(58443-0339) , analysis(58443-0339) , pack(58443-0339) , label(58443-0339)
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