Label: ERA ORGANICS MINERAL BASED SPF 15- titanium dioxide, 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 30, 2018

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  • DRUG FACTS

  • Active Ingredients

    Titanium Dioxide 3.50%

    Zinc Oxide 3.50%

    Purpose

    Sunscreen

  • SPL UNCLASSIFIED SECTION

    *Protect this product from excessive heat and direct sunlight.

  • USES:

    Helps prevent sunburn.

    If used as directed with other sun protection measure (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 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.

    - 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, along with other sun protection measures including:

    • Limit time in the sun, especially between 10am and 2pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6-months, consult a physician.
  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua, Camellia Sinensis (Green Tea) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Octyl Palmitate, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.

  • Package Labeling:

    LabelBottleApple

  • INGREDIENTS AND APPEARANCE
    ERA ORGANICS MINERAL BASED SPF 15 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72400-752
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SESAME OIL (UNII: QX10HYY4QV)  
    COCOA (UNII: D9108TZ9KG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72400-752-0259 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2018
    Labeler - Era Organics, Inc. (080454125)
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