NDC | 70581-001-30 |
Set ID | 8f01e02a-e7a9-427d-ba38-fd3aa2e67707 |
Category | HUMAN OTC DRUG LABEL |
Packager | Laboratoires Biocosm SARL |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
For sunscreen use:
- shake well before use
- apply liberally 15 minutes before sun exposure
- reaply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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 sun protection measures including:
- limit time in the sun. especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor
- Other information
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Inacitve ingredients
c12-15 alkyl benzoate, water, butylene glycol, methyl methacrylate crosspolymer polymethylsilsesquioxane, vinyl dimethicone/ methicone silsesquioxane crosspolymer, isononyl isononanoate, glycerin, dicaprylyl carbonate, pentylene glycol, polyglyceryl-6 polyricinoleate, fragrance, tocopherol, sodium chloride, phenoxyethanol, stearyl glycyrrhetinate, polyglyceryl-2 isostearate, limonene, benzyl salicylate, benzyl alcohol, linalool, tetrasodium EDTA, butylphenyl methylpropional, hexyl cinnamal
- Package Labeling:
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INGREDIENTS AND APPEARANCE
MAESTRO UV SKIN DEFENSE PRIMER SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-001 Route of Administration TOPICAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PENTYLENE GLYCOL (UNII: 50C1307PZG) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BENZYL ALCOHOL (UNII: LKG8494WBH) LINALOOL, (+/-)- (UNII: D81QY6I88E) EDETATE SODIUM (UNII: MP1J8420LU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .ALPHA.-HEXYLCINNAMALDEHYDE, (2E)- (UNII: E9947QRR9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70581-001-30 1 in 1 BOX 04/06/2016 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/06/2016 Labeler - Laboratoires Biocosm SARL (288479491) Establishment Name Address ID/FEI Business Operations Laboratoires Biocosm SARL 288479491 pack(70581-001)