CLARINS BROAD SPECTRUM SPF 15 - SUNSCREEN MULTI-ACTIVE DAY EARLY WRINKLE CORRECTING- avobenzone, homosalate, octocrylene lotion

CLARINS BROAD SPECTRUM SPF 15 - Sunscreen Multi-Active Day Early wrinkle correcting by

Drug Labeling and Warnings

CLARINS BROAD SPECTRUM SPF 15 - Sunscreen Multi-Active Day Early wrinkle correcting 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 Multi-Active Day Early wrinkle correcting lotion

Active Ingredients

AVOBENZONE 3%
HOMOSALATE 5%
OCTOCRYLENE 2.7%

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.
  

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 me dical 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 in creases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value 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 sun screen if swimming or sweating.
  

Other Information:

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

Inactive Ingredients

WATER . GLYCERIN . BUTYLOCTYL SALICYLATE . C12-15 ALKYL BENZOATE . TAPIOCA STARCH . CETEARYL ALCOHOL . TREHALOSE . HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER . POTASSIUM CETYL PHOSPHATE . BENZYL ALCOHOL . FRAGRANCE .CAPRYLYL GLYCOL .CETEARYL GLUCOSIDE . CHENOPODIUM QUINOA SEED EXTRACT . TOCOPHERYL ACETATE .DISODIUM EDTA .ORYZANOL .XANTHAN GUM . MICA . BUTYLENE GLYCOL . TOCOPHEROL . CAPRYLIC/CAPRIC TRIGLYCERIDE . ALPHA-ISOMETHYL IONONE . SUCROSE PALMITATE .GLYCERYL LINOLEATE .HYDROXY-ISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE .CITRONELLOL. LINALOOL . VERNONIA APPENDICULATA LEAF EXTRACT . CEDRELOPSIS GREVEI BARK EXTRACT . COUMARIN . GLUCOSYL HESPERIDIN . SODIUM BENZOATE .GERANIOL .BUTYLPHENYL METHYLPROPIONAL .HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . PHENOXYETHANOL . CAMELLIA SINENSIS LEAF EXTRACT . THERMUS THERMOPHILLUS FERMENT . RHODIOLA ROSEA ROOT EXTRACT . POTASSIUM SORBATE .SODIUM LAURYL SULFATE. [S1966B]

CLARINS BROAD SPECTRUM SPF 15 - Sunscreen Multi-Active Day Early wrinkle correcting lotion 50ml (

58668-1103-1)

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 15 - SUNSCREEN MULTI-ACTIVE DAY EARLY WRINKLE CORRECTING 
avobenzone, homosalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-1103
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	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TREHALOSE (UNII: B8WCK70T7I)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GAMMA ORYZANOL (UNII: SST9XCL51M)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
VERNONIA APPENDICULATA LEAF (UNII: 4SO50QHC3B)
CEDRELOPSIS GREVEI BARK (UNII: RT338M820U)
COUMARIN (UNII: A4VZ22K1WT)
GLUCOSYL HESPERIDIN (UNII: 432C95B6YE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GERANIOL (UNII: L837108USY)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-1103-1	1 in 1 CARTON	08/07/2013
1		50 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	08/07/2013

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(58668-1103)