LA DEFENSE URBAN PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (ZINC OXIDE) LOTION [LUZERN LABORATORIES, INC.]

LA DEFENSE URBAN PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (ZINC OXIDE) LOTION [LUZERN LABORATORIES, INC.]
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NDC 63127-300-01, 63127-300-02
Set ID 47662860-16d0-4a47-9741-bdfbfe6e09cc
Category HUMAN OTC DRUG LABEL
Packager Luzern Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients:

    Zinc Oxide 15%

  • Purpose

    Sunscreen

  • Uses:

    Helps prevent sunburn

  • Warnings

    For external use only

    Avoid contact with eyes.

    If contact occurs, rinse thoroughly with water. Do not use on damaged or broken skin. Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner. If swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

    Consult a health care practitioner prior to use on children less than six month of age.

  • Directions

    Apply liberally/generously (and evenly) 15 minutes before sun exposure; Reapply at least every 2 hours or after swimming, towel drying, perspiring heavily and washing; and For use on children less than 6 months of age, consult a health care practitioner.

    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:

    a. limit time in the sun, especially from 10 a.m. – 2 p.m.; and
    b. wear long-sleeved shirts, pants, hats and sunglasses.
    c. Reapply after 40 minutes of swimming or sweating; and
    d. Reapply immediately after towel drying
  • INACTIVE INGREDIENTS:

    ALGAE EXTRACT*†, BUDDLEJA DAVIDII EXTRACT**†, C12-20 ALKYL GLUCOSIDE*†, C14-22 ALCOHOLS*†, CAPRYLHYDROXAMIC ACID*†, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT*†*, CAPRYLIC/CAPRIC TRIGLYCERIDE*†, CARBOMER†, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL**†, CETYL ALCOHOL*†, CITRIC ACID*†, CUCUMIS SATIVUS (CUCUMBER) OIL*†, CYCLOPENTASILOXANE*†, ETHYLHEXYL ISONONANOATE†, ETHYLHEXYLGLYCERIN*†, GLYCERIN**†, GLYCERYL CAPRYLATE*†, GLYCERYL UNDECYLENATE*†, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT**†, HEXYLDECANOL*†, ISOSTEARYL PALMITATE*†, L-ARGININE*†, LEONTOPDOIUM ALPINUM (EDELWEISS) EXTRACT**†, METHYLCELLULOSE*†, METHYLPROPANEDIOL*†, OCTYLDODECYL NEOPENTANOATE†, PANTHENOL*†, PROPANEDIOL*†, SODIUM ASCORBYL PHOSPHATE*†, SODIUM HYALURONATE*†, SODIUM PCA*†, STEARETH-2, STEARETH-21, TAGETES ERECTA (MARIGOLD) FLOWER EXTRACT*†, TETRASODIUM GLUTAMATE DIACETATE*†, THYMUS VULGARIS (THYME) EXTRACT**†, TOCOPHERSOLAN†, TOCOPHERYL ACETATE*†, WATER (AQUA)*†, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT**†,

    *NATURAL-DERIVED / DÉRIVÉS DE NATUREL and/or ECOCERT
    **CERTIFIED ORGANIC / CERTIFIÉ ORGANIQUE USDA / ECOCERT/BIO-SWISS
    †Low Hazard Rating of “Green 0 – 2” (non-toxic, non-irritating)

  • Principal Display Panel – Carton Label

    SPF 30

    LA DEFENSE
    URBAN PROTECT
    MINERAL SUNSCREEN
    BROAD SPECTRUM SPF 30
    00-P100

    PROFESSIONAL

    For Professional Use Only.
    Pour Usage Professionnel Seulement.

    LUZERN®

    8.0 FL OZ / 240 ml

    image-01
  • INGREDIENTS AND APPEARANCE
    LA DEFENSE URBAN PROTECT  MINERAL SUNSCREEN BROAD SPECTRUM SPF30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63127-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    ARGININE (UNII: 94ZLA3W45F)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    THYME (UNII: CW657OBU4N)  
    TOCOPHERSOLAN (UNII: O03S90U1F2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63127-300-011 in 1 CARTON09/20/2017
    1240 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63127-300-021 in 1 CARTON09/20/2017
    250 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/20/2017
    Labeler - Luzern Laboratories, Inc. (188040476)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(63127-300)

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