LA DEFENSE URBAN PROTECT MINERAL BB CREAM BROAD SPECTRUM SPF20, COOL UNDERTONE (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LUZERN LABORATORIES, INC.]

LA DEFENSE URBAN PROTECT MINERAL BB CREAM BROAD SPECTRUM SPF20, COOL UNDERTONE (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LUZERN LABORATORIES, INC.]
PDF | XML

NDC 63127-400-01
Set ID d49acbca-c54e-422e-b9ab-c4db0de064e6
Category HUMAN OTC DRUG LABEL
Packager Luzern Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients:

    Zinc Oxid 7.5%

  • Purpose

    Sunscreen

  • Active Ingredients:

    Titanium Dioxide 3.0%

  • 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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. 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:

    WATER (AQUA*†), CYCLOPENTASILOXANE†, CAPRYLIC/CAPRIC TRIGLYCERIDE*†, OCTYLDODECYL NEOPENTANOATE†, SILICA*†, PROPANEDIOL*†, ETHYLHEXYL ISONONANOATE*†, DIMETHICONE, STEARETH-21, METHYLCELLULOSE*†, HEXYLDECANOL*†, CETYL ALCOHOL*†, GLYCERIN**†, SODIUM ASCORBYL PHOSPHATE*†, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL**†, SODIUM HYALURONATE*†, PANTHENOL*†, SODIUM PCA*†, TOCOPHERYL ACETATE*†, TOCOPHERSOLAN†, ALGAE EXTRACT*†, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT**†, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT**†, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT**†, BUDDLEJA DAVIDII EXTRACT**†, LEONTOPDOIUM ALPINUM (EDELWEISS) EXTRACT**†, THYMUS VULGARIS (THYME) EXTRACT**†, TAGETES ERECTA (MARIGOLD) FLOWER EXTRACT*†, C14-22 ALCOHOLS*†, ISOSTEARYL PALMITATE*†, STEARETH-2*†, C12-20 ALKYL GLUCOSIDE*†, L-ARGININE*†, CARBOMER†, CUCUMIS SATIVUS (CUCUMBER) OIL*†, CITRIC ACID*†, TETRASODIUM GLUTAMATE DIACETATE*†, CAPRYLHYDROXAMIC ACID*†, GLYCERYL CAPRYLATE*†, ETHYLHEXYLGLYCERIN*†, GLYCERYL UNDECYLENATE*†, METHYLPROPANEDIOL*†, JOJOBA ESTERS*†, IRON OXIDES (CI 77492) *†, IRON OXIDES (CI 77491) *†, IRON OXIDES (CI 77499) *†.

    *NATURAL-DERIVED / DÉRIVÉS DE NATUREL and/or ECOCERT
    **CERTIFIED ORGANIC/CERTIFIÉ ORGANIQUE USDA/ECOCERT/BIO-SUISSE
    †LOW HAZARD RATING OF “GREEN 0 – 2” (NON-TOXIC, NON-IRRITATING)

  • Principal Display Panel – Carton Label

    LA DEFENSE

    URBAN PROTECT MINERAL BB CRÈME
    BROAD SPECTRUM SPF 20

    PROTECTION URBAINE HYDRATANT QUOTIDIEN
    MINÈRALE BB ÈCRAN SOLAIRE FPS 20

    COOL UNDERTONE
    TEINTE FROIDE

    LUZERN®

    ALL SKIN TYPES   TOUS TYPES DE PEAU

    1.7 FL OZ/50 ml e

    image-01
  • INGREDIENTS AND APPEARANCE
    LA DEFENSE URBAN PROTECT  MINERAL BB CREAM BROAD SPECTRUM SPF20, COOL UNDERTONE
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63127-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-21 (UNII: 53J3F32P58)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHERSOLAN (UNII: O03S90U1F2)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GINGER (UNII: C5529G5JPQ)  
    THYME (UNII: CW657OBU4N)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    STEARETH-2 (UNII: V56DFE46J5)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63127-400-011 in 1 CARTON09/20/2017
    150 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(63127-400)

Related Drugs