Label: SPF 30 OIL-FREE MOISTURIZER- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Due to the nature of mineral formulations shake and knead the tube before use. Moisturize daily by applying generously and evenly 15 minutes before sun exposure. May be used over moisturizer or alone.
    • 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
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor.
      Après avoir nettoyé le visage le matin, appliquer sur peau humide.
  • Inactive Ingredients

    Aloe barbadensis leaf juice1, caprylic/capric triglyceride2, pentylene glycol2, polyglyceryl-6 distearate2, glyceryl stearate2, sorbitan sesquioleate2, pyrus malus (apple) juice1, vitis vinifera (grape) juice2, ascorbyl glucoside (Vitamin C), hyaluronic acid, bisabolol2, punica granatum (pomegranate) pericarp extract2, punica granatum (pomegranate) extract2, laminaria digitata (sea kelp) extract1, pongamia pinnata seed extract2, cucumis sativus (cucumber) fruit extract1, citrus limon (lemon) fruit extract2, glycerin2, xanthan gum, polyhydroxystearic acid2, sodium stearoyl glutamate, polyglyceryl-6 polyricinoleate2, maltodextrin2, citric acid, silica, iron oxides (CI 77491, CI 77492, CI 77499), jojoba esters2, simmondsia chinensis (jojoba) seed oil2.


    1
    certified organic ingredient
    2
    plant-derived
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
  • Questions?

    www.juicebeauty.com

  • PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

    jUiCE BEAUTY
    THE ORGANIC SOLUTION

    SPF 30 Oil-Free**
    Moisturizer

    broad spectrum
    SPF 30 sunscreen

    60 mL / 2 fl oz
    NPN 80040587

    Principal Display Panel - 60 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPF 30 OIL-FREE MOISTURIZER 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55165-0202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    pentylene glycol (UNII: 50C1307PZG)  
    polyglyceryl-6 distearate (UNII: Z35I17EQOP)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    sorbitan sesquioleate (UNII: 0W8RRI5W5A)  
    WINE GRAPE JUICE (UNII: JHQ6158A7R)  
    apple juice (UNII: 9871T0PD5P)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    hyaluronic acid (UNII: S270N0TRQY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    CUCUMBER (UNII: YY7C30VXJT)  
    LEMON (UNII: 24RS0A988O)  
    glycerin (UNII: PDC6A3C0OX)  
    xanthan gum (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    sodium stearoyl glutamate (UNII: 65A9F4P024)  
    polyglyceryl-6 polyricinoleate (UNII: YPM0ZOC2HR)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55165-0202-160 mL in 1 TUBE; Type 0: Not a Combination Product05/15/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02005/15/2010
    Labeler - Juice Beauty (263151582)