Label: RIPTIDE SUNSCREEN TINTED- zinc oxide paste

  • 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 February 20, 2020

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  • Drug Facts

  • Active Ingredients

    Non-Nano Zinc oxide 22%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decrease 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 product is 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 of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10am - 2pm
    • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months: ask a doctor

  • Inactive ingredients

    *Cera Alba (Beeswax), *Cocos Nucifera (Coconut) Oil, *Daucus Carota (Carrot) Seed Oil, *Theobroma Cacao (Cacao) Powder, *Vitis Vinifera (Grape) Seed Oil, *Rubus Idaeus (Red Raspberry) Seed Oil, Tocopherol (Vitamin E), *Vitellaria Paradoxa (Shea) Butter. * = Organic

  • Other information

    • protect this product from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY PACIFIC BEACH ORGANICS
    SAN DIEGO, CA 92113
    PACIFICBEACHORGANICS.COM

  • Questions or comments?

    Call 1-858-264-6354

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    RIPTIDE SUNSCREEN TINTED 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73644-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    COCOA (UNII: D9108TZ9KG)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    RASPBERRY (UNII: 4N14V5R27W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73644-001-0085.486 g in 1 JAR; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2020
    Labeler - Pacific Beach Organics Co. (117402523)
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