La Defense Broad Spectrum Spf 30 Mineral Sunscreen Lotion
FDA Label NDC 63127-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Luzern Laboratories, Inc for the product La Defense Broad Spectrum Spf 30 Mineral Sunscreen (NDC 63127-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, purpose, uses:, warnings:, keep out of reach of children., directions, inactive ingredients:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 Carton Label

LUZERN


LA DEFÉNSE

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

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Principal Display Panel – 3 Ml Tube Label

LUZERN®


LA DEFÉNSE
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

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Principal Display Panel – 240 Ml Bottle Label

PROFESSIONAL

LUZERN®


LA DEFÉNSE
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 (Image 03)

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