CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE- avobenzone, homosalate,octisalate,octocrylene,oxybenzone cream

CLARINS BROAD SPECTRUM SPF 30 Sunscreen Care by

Drug Labeling and Warnings

CLARINS BROAD SPECTRUM SPF 30 Sunscreen Care 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 30 Sunscreen Care Cream

Active ingredients

AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 5%
OCTOCRYLENE 2.7%
OXYBENZONE 3%

Purpose

Sunscreen

Uses:

• helps prevent sunburn
• if used as directed with other sun protectionmeasures (seeDirections), 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 Protect ion 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

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

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.

CLARINS BROAD SPECTRUM SPF 30 Sunscreen Care Cream 125ml (

58668-1409-1)

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE 
avobenzone, homosalate,octisalate,octocrylene,oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-1409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
PEA (UNII: W4X7H8GYFM)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
YEAST (UNII: 3NY3SM6B8U)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
ICODEXTRIN (UNII: 2NX48Z0A9G)
COUMARIN (UNII: A4VZ22K1WT)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
PLATANUS OCCIDENTALIS BARK (UNII: 85RMN3QGSE)
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: 58668-1409-1	1 in 1 CARTON	12/17/2013
1		125 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	12/17/2013

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-1409)