LOVE SUN BODY SPF 30 FRAGRANCE FREE (ZINC OXIDE) LOTION [EMILIA RESOURCES, LLC]

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LOVE SUN BODY SPF 30 FRAGRANCE FREE (ZINC OXIDE) LOTION [EMILIA RESOURCES, LLC]
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NDC 68975-010-00, 68975-010-01, 68975-010-03
Set ID 8a0f3f58-29c9-43d9-8fde-f7e756770ecc
Category HUMAN OTC DRUG LABEL
Packager Emilia Resources, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • DRUG FACT

  • Active Ingredients

    Zinc Oxide (Non-nano) 20.4%

    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

    Stop use and ask a doctor if

    rash occurs

    When using this product

    keep out of eyes, rinse with water to remove

    Keep out of reach of children.

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

  • Directions

    • For full protection, apply liberally to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect Reapply
    • After 80 minutes of swimming or sweating 
    • After towel drying
    • At least every 2 hours Sun Protection Measures
    • Spending time in the sun increases your risk of skin cancer an early 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 10am to 2pm.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Other Information

    Protect this product from excessive heat and direct sun.

    • Store at temperatures below 90°F
    • May stain some fabrics.
    • Shake bottle if separation occurs or after storing 60 days.
  • Inactive Ingredients

    Almond Oil, Aqua/Water, Benzoic Acid, Caprylic/Capric Triglyceride (Coconut Oil), Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Polyhydroxystearic Acid, Sorbitan Laurate, Sunflower Oil, Tocopherol and Xanthan Gum

  • Love Sun Body SPF 30 Fragrance Free, 25mL (68975-010-00)

    Label

  • Love Sun Body SPF 30 Fragrance Free, 100mL(68975-010-01)

    Label2

  • Love Sun Body SPF 30 Fragrance Free, 200mL (68975-010-03)

    Label3

  • INGREDIENTS AND APPEARANCE
    LOVE SUN BODY SPF 30 FRAGRANCE FREE 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68975-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION204 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    WATER (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68975-010-0025 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    2NDC:68975-010-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    3NDC:68975-010-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2019
    Labeler - Emilia Resources, LLC (079378421)
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