TRUE RADIANCE B.S. SPF 15 TITANIUM DIOXIDE SUNSCREEN TINT 113- titanium dioxide cream

True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 113 by

Drug Labeling and Warnings

True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 113 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

TITANIUM DIOXIDE 1.9%

Purpose

Sunscreen

Uses:

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only.

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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:

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-866-252-7467  Monday-Friday, 8a.m. to 5 p.m.

Package Labeling:

INGREDIENTS AND APPEARANCE

TRUE RADIANCE B.S. SPF 15 TITANIUM DIOXIDE SUNSCREEN TINT 113 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-0304
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: 58668-0304-1	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)