Label: SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN SPF 30 UVB UVA- 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 16, 2017

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  • ACTIVE INGREDIENT

    Zinc oxide 3.0%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Retains SPF after 40 minutes of activity in the water or sweating
  • 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 swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • For sunscreen use
    • Apply generously and evenly 15 minutes before sun exposure to all skin exposed to the sun
    • Reapply
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Do not remain in the sun for too long, even if you are using a sunscreen product. Even with UV light protection, direct sunlight at noontime is to be avoided. If not enough of the product is used, the sun protection provided is significantly reduced. Avoid excessive sunbathing. Do not expose infants and small children to direct sunlight. 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
    • Ask a doctor before use on children under six month of age
  • OTHER SAFETY INFORMATION

    Do not store above 25°C. protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    coco caprylate, pongamia glabra seed oil, tocopherol, capric caprylic triglyceride, polyhydroxystearic acid, cetearyl alcohol, cetearyl olivate, sorbitan olivate, water, pentylene glycol nat., carrageenan, xanthan gum, sodium polyphosphate, sodium stearoyl glutamate, cardiospermum halicacabum seed extract, glycerin, polygonum aviculare extract, simmondsia chinensis (jojoba) oil, squalene, solanum lycopersicum (tomato) fruit extract, ectoine, lactic acid, parfum (fragrance).

  • PRINCIPAL DISPLAY PANEL

    sk-sunscreen-face-MU1704015

  • INGREDIENTS AND APPEARANCE
    SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN  SPF 30 UVB UVA
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69937-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SQUALENE (UNII: 7QWM220FJH)  
    TOMATO (UNII: Z4KHF2C175)  
    ECTOINE (UNII: 7GXZ3858RY)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    CARDIOSPERMUM HALICACABUM SEED (UNII: Y5T803X015)  
    WATER (UNII: 059QF0KO0R)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69937-002-021 in 1 CARTON06/01/2017
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2017
    Labeler - Susanne Kaufmann Kosmetik GmbH (300087547)
    Registrant - Susanne Kaufmann Kosmetik GmbH (300087547)
    Establishment
    NameAddressID/FEIBusiness Operations
    Island Kinetics, Inc. d.b.a. CoValence Laboratories959735002manufacture(69937-002)
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