LA DEFENSE URBAN PROTECT MINERAL BB CREAM BROAD SPECTRUM SPF20, COOL UNDERTONE- titanium dioxide, zinc oxide lotion 
Luzern Laboratories, Inc.

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.

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La Defense Urban Protect
Mineral BB Crème Broad Spectrum SPF 20
Cool Undertone

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
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 CARTON09/20/201702/29/2020
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 finalpart35209/20/201702/29/2020
Labeler - Luzern Laboratories, Inc. (188040476)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(63127-400)

Revised: 12/2019
 
Luzern Laboratories, Inc.