Label: PHARMACA NATURAL MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide cream

  • NDC Code(s): 62082-055-03
  • Packager: Pharmaca Integrative Pharmacy, Inc.
  • 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 May 30, 2019

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

  • DRUG FACTS

  • Active Ingredients

    Titanium Dioxide, 6.0%

    Zinc Oxide, 6.0%

    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. Keep product out of eyes. Rinse with water to remove. 

    Stop use and consult physician

    if irritation or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions:

    Apply liberally 15 minutes before sun exposure. Reapply at least every two hours, and immediately after swimming, sweating or towel drying. Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad-spectrum protection and an SPF rating of 15 or higher. Other recommendations: Limit time in sleeve shirts, pants, hats and sunglasses. For children under 6 months, consult a physician.

  • Other ingredients:

    aloe barbadensis (aloe vera gel) juice, aqua (deionized water), butyrospermum parkii (shea) butter, camellia sinensis (green tea) extract, cocos nucifera (coconut) oil, dehydroxanthan gum, gluconolactone, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) oil, lecithin, mangifera indica, (mango) butter, sodium benzoate, sodium laurylglucosides hydroxypropylsulfonate, styrene/acrylates copolymer, tocopheryl (vitamin e), xanthan gum

  • For maximum effectiveness:

    Protect this product from excessive heat and direct sunlight.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PHARMACA NATURAL MINERAL SUNSCREEN SPF-30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62082-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    MANGIFERA INDICA BARK (UNII: S242WH4US3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62082-055-03100 mL in 1 TUBE; Type 0: Not a Combination Product05/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/20/2019
    Labeler - Pharmaca Integrative Pharmacy, Inc. (031903446)