BB SKIN PERFECTING BROAD SPECTRUM SPF 25 TITANIUM DIOXIDE - SUNSCREEN - SHADE DARK 03- titanium dioxide cream

BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Dark 03 by

Drug Labeling and Warnings

BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Dark 03 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A., Laboratoires Clarins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

TITANIUM DIOXIDE 4.7%

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.

Warning

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 the risk, regularly use a sunscreen with a board spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10a.m. - 2p.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

WATER, DIMETHICONE, ISONONTL, ISONONANOATE, GLYCERIN, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, C12-15 ALKYL BENZOATE, POLYMETHYL METHACRYLATE, POLYGLYCERYL-3 RICINOLEATE, SORBITAN OLEATE, PEG-10 DIMETHICONE, SILICA, PEG-30 DIPOLYHYDROXYSTEARATE, MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLUMER, MITHICONE, PHENOXYTHANOL, FRAGRANCE, STEARALKONIUM HECTORITE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYGLYCERYL-2 CAPRATE, MICA, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, PROPILENE CARBONATE, SORBIC ACID, DIMETHICONOL, SODIUM HYALURONATE, BUTYLPHENYL METHYLPROPIONAL, HEXYL CINNAMAL, BENZYL BENZOATE, ACTINIDIA CHINENSIS (KIWI) FRUIT EXTRACT, CEDRELOPSIS GREVEI BARK EXTRACT, TRIETHOXYCAPRYLYSILANE, THERMUS THERMOPHILLUS FERMENT, ALPHA-ISOMETHYL IONONE, LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT, LINALOOL, CITRONELLOL, LIMONENE, EUGENOL, CAMELLIA SINENSIS LEAF EXTRACT, POTASSIUM SORBATE, SODIUM LAURYL SULFATE.
+/- MAY CONTAIN/PEUT CONTENIR : TITANIUM DIOXIDE, IRON OXIDES [M2444B].

Other Information:

• protect the product in this container from excessive heat and direct sun.

Questioins or comments?

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

SPL UNCLASSIFIED SECTION

The power of skin care and makeup is combined in this rich, creamy, 3-in-1 skin perfecting formula to promote more beautiful-looking skin abd a flawless complexion in one easy step. Imperfections,, fine lines and wrinkles are visibly less noticeable while dull, tired-looking skin is instantly revitalized and protected from potential aggressions. Skin look radiant and feels very comfortable. Natural-looking results: a more even skin tone and enhanced radiance without looking like you're wearing makeup!
Satin finish - Light to medium coverage For all skin types.
Anti-pollution protection. Non-comedogenic. Dermatologist tested. SPF 25. Oil-free.

CLARINS PARIS 92200 Neuilly 95300 Pontoise - France Made in France

Product Labels

CLARINS PARIS 01 BB Skin Perfecting Cream Board Specturm SPF 25 Titanium Dioxide - Sunscreen Revitalizes, Protects Evens Skin Tone e 45 mL 1.7 Oz. Net Wt.

INGREDIENTS AND APPEARANCE

BB SKIN PERFECTING BROAD SPECTRUM SPF 25 TITANIUM DIOXIDE - SUNSCREEN - SHADE DARK 03 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-0107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	47 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MICA (UNII: V8A1AW0880)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SORBIC ACID (UNII: X045WJ989B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL BENZOATE (UNII: N863NB338G)
KIWI FRUIT (UNII: 71ES77LGJC)
CEDRELOPSIS GREVEI BARK (UNII: RT338M820U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
EUGENOL (UNII: 3T8H1794QW)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-0107-1	1 in 1 CARTON	11/18/2014
1		45 mL in 1 TUBE; 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	11/18/2014

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins		266317555	manufacture(58668-0107)