Label: TRADER JOE S MINERAL SUNSCREEN- zinc oxide stick

  • 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 25, 2017

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

  • Drug Facts

  • Active ingredient

    Zinc Oxide 22.0%

  • 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.

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply liberally to face and body 15 minutes before sun exposure. • Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. • Children under 6 months: ask a doctor. • 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 15 value or higher along with 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.

  • Other information

    • May stain some fabrics. • Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Argania Spinosa Kernel Oil, Beeswax, Bisabolol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Octyldodecanol, Persea Gratissima (Avocado) Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

  • Questions or comments?

    1- 626-599-3700 Monday – Friday 9 AM – 5 PM PST

  • SPL UNCLASSIFIED SECTION

    Non-Nano Zinc Oxide

    BROAD SPECTRUM SPF 50

    Water Resistant
    (80 Minutes)

    Fragrance Free

    PABA Free

    Our Mineral Sunscreen Stick is formulated with natural mineral zinc oxide to protect skin from sun exposure and sunburn. Our stick formula glides on smoothly with added coconut and avocado oils and natural waxes to moisturize. Featuring a compact design, this twist up stick offers easy, quick application on-the-go.

    Water-resistant up to 80 minutes for continued protection in and out of the water. Fragrance free, PABA free and formula never tested on animals.

    DIST. & SOLD EXCLUSIVELY BY:

    TRADER JOE’S, MONROVIA, CA 91016

  • Packaging

    Sunscreen Stick

  • INGREDIENTS AND APPEARANCE
    TRADER JOE S MINERAL SUNSCREEN 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71270-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71270-150-031 in 1 BLISTER PACK02/25/2017
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/25/2017
    Labeler - Trader Joe's Company (006226666)