CLARINS BROAD SPECTRUM SPF 50 PLUS - SUNSCREEN CARE MILK- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray 
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 50+ - SUNSCREEN CARE MILK-LOTION SPRAY

CLARINS BROAD SPECTRUM SPF 50+ - SUNSCREEN CARE MILK-LOTION SPRAY


Active ingredients

AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 5%
OCTOCRYLENE 2.7%
OXYBENZONE 6%

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 in creases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectru m 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 sun screen if swimming or sweating

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.

Inactive ingredients

AQUA/WATER/EAU. C12-15 ALKYL BENZOATE . BUTYLOCTYL SALICYLATE . BUTYLENE GLYCOL. DIPROPYLENE GLYCOL DIBENZOATE.POLYESTER-7. DIMETHICONE . NEOPENTYL GLYCOL DIHEPTANOATE .ALOE BARBADENSIS LEAF JUICE . MANNITOL . GLYCERIN . PPG-15 STEARYL ETHER BENZOATE . PHENOXY-ETHANOL .LAURYL GLUCOSIDE .PARFUM/FRAGRANCE .POLYGLYCERYL- 2 DIPOLYHYDROXYSTEARATE . POTASSIUM CETYL PHOSPHATE .AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER . DIMETHICONOL . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . TOCOPHEROL .CYCLODEXTRIN .DEHYDROACETIC ACID .PISUM SATIVUM (PEA) EXTRACT .TROMETHAMINE . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE .CITRIC ACID .DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . PLATANUS OCCIDENTALIS BARK EXTRACT.POTASSIUM SORBATE.SODIUM BENZOATE . BENZYL SALICYLATE . LIMONENE . BUTYLPHENYL METHYLPROPIONAL . HEXYL CINNAMAL . CITRONELLOL. [S2031A]

CLARINS BROAD SPECTRUM SPF 50+ - SUNSCREEN CARE MILK-LOTION SPRAY 150ml (58668-4101-1)

Inner PackageOuter Package

CLARINS BROAD SPECTRUM SPF 50 PLUS - SUNSCREEN CARE MILK 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-4101
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) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
POLYESTER-7 (UNII: 0841698D2F)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MANNITOL (UNII: 3OWL53L36A)  
GLYCERIN (UNII: PDC6A3C0OX)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
PEA (UNII: W4X7H8GYFM)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
YEAST (UNII: 3NY3SM6B8U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
PLATANUS OCCIDENTALIS BARK (UNII: 85RMN3QGSE)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58668-4101-11 in 1 CARTON05/08/201312/15/2019
1150 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 finalpart35205/08/201312/15/2019
Labeler - Laboratoires Clarins S.A. (266317555)
Registrant - Laboratoires Clarins S.A. (266317555)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.266317555manufacture(58668-4101)

Revised: 11/2021
Document Id: d053a1d2-3313-b4b9-e053-2995a90ace8c
Set id: 1998b8ac-d38a-4c76-ab97-f64c40a87f28
Version: 4
Effective Time: 20211108
 
Laboratoires Clarins S.A.