Label: LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN- zinc oxide, titanium dioxide lotion
- NDC Code(s): 63127-101-01, 63127-101-02, 63127-101-03
- Packager: Luzern Laboratories, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- Official Label (Printer Friendly)
- Active Ingredients:
- Purpose
- Uses:
-
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. -
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
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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 lotionProduct 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)
