Label: SUNSCREEN SPF 30- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 10, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    ZINC OXIDE 20%
  • PURPOSE

    PURPOSE

    SUNSCREEN

  • INDICATIONS & USAGE

    • HELPS PREVENT SUNBURN
  • WARNINGS

    WARNINGS
    • FOR EXTERNAL USE ONLY
  • DO NOT USE

    • DO NOT USE ON DAMAGED OR BROKEN SKIN.
  • WHEN USING

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

    Directions
    • apply liberally 15 minutes before sun exposure.
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
  • OTHER SAFETY INFORMATION

    • 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 10 a.m.–2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
  • PEDIATRIC USE

    • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR
  • INACTIVE INGREDIENT

    Inactive ingredients: *Aloe barbadensis leaf juice, *anthemis nobilis (chamomile) flower oil, caprylic/capric triglycerides, *helianthus annuus (sunflower) seed oil, hydrogenated methyl abietate, *lavandula angustifolia (lavender) flower oil, magnesium sulfate, *olea europaea (olive) fruit oil, polyaminopropyl biguanide, polyglycerol-10 laurate, ricinus communis (castor) seed oil, *simmondsia chinensis (jojoba) seed oil, sorbitan stearate, tocopherol, water.
  • STORAGE AND HANDLING

    OTHER INFORMATION
    • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
  • PRINCIPAL DISPLAY PANEL

    ERBAVIVA

    SUNSCREEN
    SPF30


    Completely natural broad spectrum
    sunscreen, for children and adults.

    EBV_2ozTubes_Sunscreen_NewFDA_m2b

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN  SPF 30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43239-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43239-201-1375 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/10/2012
    Labeler - ERBAVIVA INC. (006459540)
    Registrant - ERBAVIVA INC. (006459540)
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