CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN EXTRA-FIRMING FOUNDATION TINT 113- titanium dioxide cream

CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 113 by

Drug Labeling and Warnings

CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 113 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 113

Active Ingredient

Titanium Dioxide 2.5%

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 sking 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 a 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 . CYCLOPENTASILOXANE  ISONONYL ISONONANOATE . BUTYLENE GLYCOL . TALC . DIMETHICONE . POLYGLYCERYL-3 RICINOLEATE . SORBITAN OLEATE . PEG-30 DIPOLYHYDROXYSTEARATE . MAGNESIUM SULFATE . SILICA . PHENOXYETHANOL . MAGNESIUM STEARATE . POLYHYDROXYSTEARIC ACID . DIMETHICONOL .  DISTEARDIMONIUM HECTORITE . DIMETHICONE  CROSSPOLYMER . PARFUM/FRAGRANCE . SORBIC ACID . AVENA SATIVA (OAT) KERNEL EXTRACT . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . HYDROXYETHYL UREA . LAUROYL LYSINE . CAMELLIA  SINENSIS LEAF EXTRACT . ALGIN . SODIUM BENZOATE . ACACIA SENEGAL GUM . LAPSANA  COMMUNIS FLOWER/LEAF/STEM EXTRACT . PLANTAGO MAJOR SEED EXTRACT . ALPHAISOMETHYL IONONE . LINALOOL . HEXYL CINNAMAL . LIMONENE.

 MAY CONTAIN/PEUT CONTENIR: CI 77891/TITANIUM DIOXIDE . MICA . CI 77491/CI 77492/ CI 77499/ IRON OXIDES. M2060A

Other Information / Questions or Comments

Protect this product from excessive heat and direct sun

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

SPL UNCLASSIFIED SECTION

The perfect match between make-up and skin care. A creamy rich foundation that combines exceptional skin firming and age-fighting ingredients for a visibly younger-looking complexion. Delivers a smooth, more radiant, even complexion.
Satin finish - Medium coverage - All skin types. Oil-free. Non-comedogenic. Dermatologist tested.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN EXTRA-FIRMING FOUNDATION TINT 113 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-2031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBIC ACID (UNII: X045WJ989B)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
LAUROYL LYSINE (UNII: 113171Q70B)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ACACIA (UNII: 5C5403N26O)
LAPSANA COMMUNIS WHOLE (UNII: UXH42V064J)
PLANTAGO MAJOR SEED (UNII: YP0NFQ834U)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-2031-1	1 in 1 PACKAGE	05/06/2010
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 final	part352	05/06/2010

Labeler - Laboratoires Clarins S.A. (266317555)

Registrant - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-2031)