SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [ERBAVIVA INC.]

SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [ERBAVIVA INC.]
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NDC 43239-201-13
Set ID d0d494f0-da15-482b-ac7d-2626764c06ef
Category HUMAN OTC DRUG LABEL
Packager ERBAVIVA INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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