BABY SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [SEVENTH GENERATION INC]

BABY SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [SEVENTH GENERATION INC]
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NDC 42263-101-13
Set ID c17dec08-5749-424d-8139-1fc0a10515de
Category HUMAN OTC DRUG LABEL
Packager SEVENTH GENERATION INC
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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