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| Product NDC Code | 63127-101 | ||||||||
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| Drug Name | La defense broad spectrum spf 30 mineral sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Luzern Laboratories, Inc | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Zinc Oxide (CI 77947) 15% Titanium Dioxide 3.57%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: Helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.La Defense Broad Spectrum SPF 30 Mineral Sunscreen Zinc Oxide, Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ARGAN OIL LEVOMENOL BUDDLEJA DAVIDII LEAF C12-20 ALKYL GLUCOSIDE C14-22 ALCOHOLS GREEN TEA LEAF CAPRYLHYDROXAMIC ACID MEDIUM-CHAIN TRIGLYCERIDES CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL CHONDRUS CRISPUS CARRAGEENAN CITRIC ACID MONOHYDRATE ETHYL MACADAMIATE ETHYLHEXYL ISONONANOATE ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOCAPRYLATE GLYCERYL ISOSTEARATE GLYCERYL 1-UNDECYLENATE GLYCYRRHIZA GLABRA SUNFLOWER OIL HEXYLDECANOL ISOSTEARYL PALMITATE ARGININE LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP LEVULINIC ACID METHYLPROPANEDIOL OCTYLDODECYL NEOPENTANOATE PANTHENOL POLYHYDROXYSTEARIC ACID STEARATE PROPANEDIOL SODIUM ASCORBYL PHOSPHATE HYALURONATE SODIUM SODIUM LEVULINATE SODIUM PYRROLIDONE CARBOXYLATE STEARETH-2 STEARETH-21 THYME TOCOPHEROL TOCOPHERSOLAN .ALPHA.-TOCOPHEROL ACETATE WATER GINGER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. Consult a health care practitioner prior to use on children less than six months of age.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect the product in this container from excessive heat and direct sunlight. Comments and Questions: 1-888-591-7800
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API