Label: VIVAOIDAYS SUNSCREEN WITH TURMERIC- 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 June 20, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Zinc Oxide 20%

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  • Purpose

    Sunscreen

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  • 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
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  • 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.

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  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately 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
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  • Inactive ingredients

    SIMMONDSIA CHINENSIS (JOJOBA)SEED OIL 1, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL 1, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYROSPERMUM PARKII (SHEA) BUTTER 1, CERA ALBA/BEESWAX 1, HYDROGENATED VEGETABLE OIL, GLYCERYL STEARATE, OLEA EUROPAEA (OLIVE) FRUIT OIL 1, PARFUM, POLYHYDROXYSTEARIC ACID, HIPPOPHAE RHAMNOIDES (SEABUCKTHORN) FRUIT OIL 1, TOCOPHEROL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT 1, CALENDULA OFFICINALIS (CALENDULA) FLOWER EXTRACT 1.


    1
    From organic farming.
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  • Other information

    • protect the product from excessive heat and direct sun
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  • Questions or comments?

    To report serious adverse event, call 310-453-0137 or email: Support@vivaiodays.com

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  • PRINCIPAL DISPLAY PANEL - 100 ml Tube Label

    VIVAIODAYS

    Organic World Secrets for baby & kid

    SUNSCREEN
    WITH TURMERIC

    inspired by Borneo

    30
    BROAD SPECTRUM SPF 30

    NON-NANO
    ZINC OXIDE
    WATER RESISTANT
    40 Minutes
    EASY TO APPLY

    • MADE WITH 59.14% ORGANIC INGREDIENTS
    COSMOS
    ORGANIC

    100ml / 3.4 fl.oz

    PRINCIPAL DISPLAY PANEL - 100 ml Tube Label
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  • INGREDIENTS AND APPEARANCE
    VIVAOIDAYS SUNSCREEN WITH TURMERIC 
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71778-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 200 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    TURMERIC (UNII: 856YO1Z64F)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71778-001-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 02/15/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 02/15/2018
    Labeler - 5 SENCO Inc. (055882668)
    Establishment
    Name Address ID/FEI Business Operations
    Stasinos Sikalias 363281305 manufacture(71778-001)
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