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

La Defense Broad Spectrum SPF 30 Mineral Sunscreen by

Drug Labeling and Warnings

La Defense Broad Spectrum SPF 30 Mineral Sunscreen 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]

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

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

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

INGREDIENTS AND APPEARANCE

LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63127-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.57 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63127-101-01	1 in 1 CARTON	05/10/2021
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63127-101-02	3 mL in 1 TUBE; Type 0: Not a Combination Product	05/10/2021
3	NDC: 63127-101-03	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/10/2021

Labeler - Luzern Laboratories, Inc (188040476)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(63127-101)