Label: BABY 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 March 26, 2012

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  • ACTIVE INGREDIENT

    ZINC OXIDE 20%
  • PURPOSE

    SUNSCREEN

  • INDICATIONS & USAGE

    Other Information
    • protect the product in this container from excessive heat and direct sun
  • WARNINGS

    Warnings
    For external use only
  • DO NOT USE

    Do not use on damaged or broken skin.
  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.
  • STOP USE

    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
    • reapply:
    •     after 80 minutes of swimming or sweating
    •     immediately after towel drying
    •     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 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
  • PEDIATRIC USE

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

    Inactive ingredients Aloe barbadensis leaf juice, anthemis
    nobilis flower oil, caprylic/capric triglycerides, helianthus annuus seed
    oil, hydrogenated methyl abietate, lavandula angustifolia flower oil,
    magnesium sulfate, olea europaea fruit oil, polyaminopropyl
    biguanide, polyglycerol-10 laurate, ricinus communis seed oil,
    simmondsia chinensis 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

    SEVENTH GENERATION

    FOR THE WEE GENERATION

    BABY SUNSCREEN
    BROAD SPECTRUM SPF 30
    SG Baby Sunscreen ART 2012-03-26_Label

  • INGREDIENTS AND APPEARANCE
    BABY SUNSCREEN  SPF 30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42263-101
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42263-101-1385 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/30/2011
    Labeler - SEVENTH GENERATION INC (178161212)
    Registrant - SEVENTH GENERATION INC (178161212)
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