CLARINS BROAD SPECTRUM SPF 15 - SUNSCREEN MULTI-ACTIVE DAY EARLY WRINKLE CORRECTING- avobenzone, homosalate, octocrylene lotion 
Laboratoires Clarins S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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)

Insert 2Inner LabelOuter Label

CLARINS BROAD SPECTRUM SPF 15 - SUNSCREEN MULTI-ACTIVE DAY EARLY WRINKLE CORRECTING 
avobenzone, homosalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-1103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58668-1103-11 in 1 CARTON08/07/201312/15/2019
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/07/201312/15/2019
Labeler - Laboratoires Clarins S.A. (266317555)
Registrant - Laboratoires Clarins S.A. (266317555)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.266317555manufacture(58668-1103)

Revised: 11/2021
Document Id: d0416649-1512-24f2-e053-2995a90ae73f
Set id: 570b6aca-80dd-4109-ae1a-685a92577453
Version: 4
Effective Time: 20211108
 
Laboratoires Clarins S.A.