NDC | 58668-0296-1 |
Set ID | 86157467-356b-4cb7-abb0-14cdee045f9c |
Category | HUMAN OTC DRUG LABEL |
Packager | Laboratoires Clarins |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active ingredient
- Uses:
- Warnings:
-
Directions:
• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• children under 6 months: Ask a doctor
• 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 broad spectrum SPF 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
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating -
Inactive ingredients
AQUA/WATER/EAU, DICAPRYLYL CARBONATE, DIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, CETYL PEG/PPG-10/1 DIMETHICONE, C12-15 ALKYL BENZOATE, SILICA, METHYL METHYL METHACRYLATE CROSSPOLYMER, MICA, SODIUM CHLORIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALUMINUM HYDROXIDE, PHENOXYETHANOL, PARFUM/FRAGRANCE, STEARIC ACID, ETHYLHEXYLGLYCERIN, STEARALKONIUM HECTORITE, DISDIUM EDTA, TOCOPHERYL ACETATE, HYDROLYZED CAESALPINIA SPINOSA GUM, SORBIC ACID, PROPYLENE CARBONATE, SODIUM LAUROYL GLUTAMATE, SALICORNIA HERBACEA EXTRACT, CAESALPINIA SPINOSA GUM, LYSINE, MORINGA PTERYGOSPERMA SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, MAGNESIUM CHLORIDE, LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT, DISODIUM PHOSPHATE, CITRIC ACID, POTASSIUM SORBATE, SODIUM BENZOATE. +/- MAY CONTAIN: CI77891/TITANIUM DIOXIDE, CI77491/CI77492/CI77499/IRON OXIDES. [M2615A]
- Other information:
- Questions or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
TRUE RADIANCE B.S. SPF 15 TITANIUM DIOXIDE SUNSCREEN TINT 105
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58668-0296 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 19 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) SODIUM CHLORIDE (UNII: 451W47IQ8X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SORBIC ACID (UNII: X045WJ989B) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33) SALICORNIA EUROPAEA (UNII: 6ADL50JAKW) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) LYSINE (UNII: K3Z4F929H6) MORINGA OLEIFERA SEED (UNII: TIX5482832) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58668-0296-1 1 in 1 CARTON 09/22/2015 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 09/22/2015 Labeler - Laboratoires Clarins (266317555)