La Defense Urban Protect Mineral Sunscreen Broad Spectrum SPF30

La Defense Urban Protect by

Drug Labeling and Warnings

La Defense Urban Protect by is a Otc medication manufactured, distributed, or labeled by Luzern Laboratories, Inc., Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LA DEFENSE URBAN PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF30- 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 Sunscreen Broad Spectrum SPF30

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
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 CARTON09/20/201702/29/2020
1240 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 63127-300-021 in 1 CARTON09/20/201702/29/2020
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 finalpart35209/20/201702/29/2020
Labeler - Luzern Laboratories, Inc. (188040476)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(63127-300)

Revised: 1/2020