Label: PEOPLE4OCEAN SPF50 SUNSCREEN VEGAN- zinc oxide cream

  • 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 July 1, 2020

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  • Drug Facts

  • Active ingredient

    Zinc oxide 22.5%

    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.

    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.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • Reapply:
    • after 80 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 value 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-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor
  • Other information

    • store below 86°F (30°C)
    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    caprylic/capric triglycerideº, castor oilº, candelilla wax*, coco-caprylate/caprateº, coconut oilº, tocopherol acetateº, polyglyceryl-3 polyricinoleateº, lavender oil*, ylang ylang flower oil*, patchouli leaf oil*, vetiver root oil*, geranium oil*, isostearic acidº. ºOrganic |*Natural.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PEOPLE4OCEAN SPF50 SUNSCREEN VEGAN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73192-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION225 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73192-020-00100 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2019
    Labeler - P4O Distribution Pty Ltd (745079594)
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