LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN- zinc oxide, titanium dioxide lotion 
Luzern Laboratories, Inc

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La Défense Broad Spectrum SPF 30 Mineral Sunscreen

Active Ingredients:

Zinc Oxide (CI 77947) 15%
Titanium Dioxide 3.57%

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 months 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 measures including:

Limit time in the sun, especially from 10am – 2pm.
Wear Long-sleeved shirts, pants, hats and sunglasses.
Reapply after 40 minutes of swimming or sweating.
Reapply immediately after towel drying.

Inactive Ingredients:

ARGANIA SPINOSA (ARGAN) KERNEL OIL, BISABOLOL, BUDDLEJA DAVIDII LEAF EXTRACT, C1220 ALKYL GLUCOSIDE, C1422 ALCOHOLS, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CAPRYLHYDROXAMIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, CARBOMER, CETYL ALCOHOL, CHONDRUS CRISPUS EXTRACT, CITRIC ACID, ETHYL MACADAMIATE, ETHYLHEXYL ISONONANOATE, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), GLYCERIN, GLYCERYL CAPRYLATE , GLYCERYL ISOSTEARATE, GLYCERYL UNDECYLENATE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HEXYLDECANOL, ISOSTEARYL PALMITATE, JOJOBA ESTERS, L-ARGININE, LEONTOPODIUM ALPINUM (EDELWEISS) FLOWER/LEAF EXTRACT, LEVULINIC ACID, METHYLPROPANEDIOL, OCTYLDODECYL NEOPENTANOATE, PANTHENOL, POLYHYDROXYSTEARIC ACID, PROPANEDIOL, SODIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, SODIUM LEVULINATE, SODIUM PCA, STEARETH-2, STEARETH-21, TETRASODIUM GLUTAMATE DIACETATE, THYMUS VULGARIS (THYME) FLOWER/LEAF EXTRACT, TOCOPHEROL, TOCOPHERSOLAN, TOCOPHERYL ACETATE, WATER (AQUA), ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT.

Other information

Protect the product in this container from excessive heat and direct sunlight.

Comments and Questions:
1-888-591-7800

Principal Display Panel – 60 mL Tube Label

LUZERN


LA DÉFENSE

BROAD SPECTRUM SPF 30
MINERAL SUNSCREEN

2.0 FL OZ / 60 ml℮


Manufactured for and dist. by/Fabriqué pour et distribué par
Luzern Laboratories, Inc
50 Washington Street, Norwalk, CT 06854 / Biorius / UK: Shelton Street 71-
London WC2H9JQ, Great-Britain / EU: Rue Wauters 113-7170 Manage, Belgium

image-01

Principal Display Panel – 3 mL Tube Label

LUZERN®


LA DÉFENSE
BROAD SPECTRUM SPF 30
MINERAL SUNSCREEN


0.1 FL OZ / 3 ml℮


Manufactured for and dist. by/Fabriqué pour et distribué par Luzern Laboratories, Inc
50 Washington Street, Norwalk, CT 06854 / Biorius / UK: Shelton Street 71-
London WC2H9JQ, Great-Britain / EU: Rue Wauters 113-7170 Manage, Belgium

image-02

Principal Display Panel – 240 mL Bottle Label

PROFESSIONAL

LUZERN®


LA DÉFENSE
BROAD SPECTRUM
SPF 30
MINERAL SUNSCREEN


8.0 FL OZ / 240 ml℮


Manufactured for and dist. by/Fabriqué pour et distribué par Luzern Laboratories, Inc
50 Washington Street, Norwalk, CT 06854 / Biorius / UK: Shelton Street 71-
London WC2H9JQ, Great-Britain / EU: Rue Wauters 113-7170 Manage, Belgium

image-03
LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63127-101
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.57 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARGAN OIL (UNII: 4V59G5UW9X)  
LEVOMENOL (UNII: 24WE03BX2T)  
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HEXYLDECANOL (UNII: 151Z7P1317)  
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
ARGININE (UNII: 94ZLA3W45F)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
LEVULINIC ACID (UNII: RYX5QG61EI)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
THYME (UNII: CW657OBU4N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TOCOPHERSOLAN (UNII: O03S90U1F2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
GINGER (UNII: C5529G5JPQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63127-101-011 in 1 CARTON05/10/2021
160 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:63127-101-023 mL in 1 TUBE; Type 0: Not a Combination Product05/10/2021
3NDC:63127-101-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/10/2021
Labeler - Luzern Laboratories, Inc (188040476)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(63127-101)

Revised: 12/2023
Document Id: 32384173-e9d9-4f6e-af92-57f89ea3de61
Set id: 3f00befa-415d-415d-89e1-6ba8770ba51e
Version: 2
Effective Time: 20231221
 
Luzern Laboratories, Inc