CLARINS EXTRA-COMFORT BROAD SPECTRUM SPF 15 SUNSCREEN TINT 105- titanium dioxide liquid

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 105 by

Drug Labeling and Warnings

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 105 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 105

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 . DIMETHICONE . PHENYL TRIMETHICONE . BUTYLENE GLYCOL . PEG/ PPG-18/18 DIMETHICONE . STEARYL DIMETHICONE . C12-15 ALKYL BENZOATE . GLYCERIN . ARGANIA SPINOSA KERNEL OIL . SODIUM CHLORIDE . VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER . SILICA . POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE . ALUMINUM HYDROXIDE . PARFUM/FRAGRANCE . STEARIC ACID . PHENOXYETHANOL . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . ETHYLHEXYLGLYCERIN . DISODIUM EDTA . STEARALKONIUM HECTORITE . TOCOPHERYL ACETATE . MICA . HYDROXYETHYL UREA . SORBIC ACID . SODIUM LAUROYL GLUTAMATE . PROPYLENE CARBONATE . TOCOPHEROL . LYSINE . PERICHLAENA RICHARDII LEAF EXTRACT . CAMELLIA SINENSIS LEAF EXTRACT . MAGNESIUM CHLORIDE . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . ALGIN . ACACIA SENEGAL GUM . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . PALMITOYL DIPEPTIDE-5 DIAMINOHYDROXYBUTYRATE. ± / MAY CONTAIN/PEUT CONTENIR : CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES [M2374A].

Other information:

• protect this product from excessive heat and direct sun.
  

Questions or comments?

Call 1-866-252-7467 (In the US) Monday-Friday 8 a.m. to 5 p.m.

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 105 30ml (

58668-6120-1)

INGREDIENTS AND APPEARANCE

CLARINS EXTRA-COMFORT BROAD SPECTRUM SPF 15 SUNSCREEN TINT 105  
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-6120
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ARGAN OIL (UNII: 4V59G5UW9X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MICA (UNII: V8A1AW0880)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SORBIC ACID (UNII: X045WJ989B)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TOCOPHEROL (UNII: R0ZB2556P8)
LYSINE (UNII: K3Z4F929H6)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
ACACIA (UNII: 5C5403N26O)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACID (UNII: 1MGA33DQ5R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-6120-1	1 in 1 CARTON	05/27/2014
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/27/2014

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-6120)