CLARINS BROAD SPECTRUM SPF 15 TITANIUM DIOXIDE-SUNSCREEN EXTRA-FIRMING FOUNDATION TINT 103- titanium dioxide liquid

CLARINS Broad Spectrum SPF 15 Titanium Dioxide-Sunscreen Extra-Firming Foundation Tint 103 by

Drug Labeling and Warnings

CLARINS Broad Spectrum SPF 15 Titanium Dioxide-Sunscreen Extra-Firming Foundation Tint 103 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 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 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:

• Protect this product from excessive heat and direct sun.
  

Questions or comments?

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

Laboratoires Clarins S.A.

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.

CLARINS PARIS   92200 Neuilly    95300 Pontoise - France   Made in France   Patent application (WO)

PRINCIPAL DISPLAY PANEL

CLARINS PARIS 103 Teint Broad Spectrum SPF 15 Titanium Dioxide - Sunscreen Extra-Firming Foundation 30 mL 1.1 Oz. Net Wt.

Product Labels

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 15 TITANIUM DIOXIDE-SUNSCREEN EXTRA-FIRMING FOUNDATION TINT 103 
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-1931
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
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)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBIC ACID (UNII: X045WJ989B)
OAT (UNII: Z6J799EAJK)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
LAUROYL LYSINE (UNII: 113171Q70B)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ACACIA (UNII: 5C5403N26O)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
PLANTAGO MAJOR SEED (UNII: YP0NFQ834U)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-1931-1	1 in 1 CARTON	09/16/2014
1		30 mL in 1 CONTAINER; 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	09/16/2014

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-1931)