LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN (ZINC OXIDE) LOTION [LUZERN LABORATORIES, INC]

LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN (ZINC OXIDE) LOTION [LUZERN LABORATORIES, INC]
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NDC 63127-100-01
Set ID cd2106be-7439-40d0-b4f0-b3b51134bb98
Category HUMAN OTC DRUG LABEL
Packager Luzern Laboratories, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Zinc Oxide (CI 77947) 15%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner.

    Keep out of reach of children.

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

  • Directions

    Apply liberally before sun exposure. Reapply every 2 hours of sun exposure, or after swimming, excessive perspiration, or 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†, CETYL ALCOHOL*†, CITRIC ACID*†, CUCUMIS SATIVUS (CUCUMBER) OIL**†, CYCLOMETHICONE†, 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, 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-SUISSE
    † ENVIRONMENTAL WORKING GROUP (EWG) LOW HAZARD RATING OF “GREEN 0 – 2” (NON-TOXIC, NON-IRRITATING)

  • Principal Display Panel - Carton Label

    LA DEFENSE

    BROAD SPECTRUM SPF 30
    MINERAL SUNSCREEN

    LARGE SPECTRE SPF 30
    PROTECTION SOLAIRE MINÉRALE

    LUZERN®
    LABORATORIES

    ALL SKIN TYPES • TOUS TYPES DE PEAU

    1.7 FL OZ / 50 ml

    Carton Label.jpg
  • INGREDIENTS AND APPEARANCE
    LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63127-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    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)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    ARGININE (UNII: 94ZLA3W45F)  
    LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)  
    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:63127-100-011 in 1 CARTON03/13/2014
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/13/2014
    Labeler - Luzern Laboratories, Inc (188040476)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(63127-100)

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