CLARINS EXTRA-COMFORT BROAD SPECTRUM SPF 15 SUNSCREEN TINT 113- titanium dioxide liquid 
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.

----------

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113


Active Ingredient:

TITANIUM DIOXIDE:1.9%

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 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 at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

Inactive Ingredients:

AQUA/WATER/EAU . DIMETHICONE . PHENYL TRIMETHICONE . BUTYLENE GLYCOL . PEG/ PPG-18/18 DIMETHICONE . STEARYL DIMETHICONE . C12-15 ALKYL BENZOATE . GLYCERIN . ARGANIA SPINOSA KERNEL OIL . SODIUM CHLORIDE . VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER . SILICA . POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE . ALUMINUM HYDROXIDE . PARFUM/FRAGRANCE . STEARIC ACID . PHENOXYETHANOL . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . ETHYLHEXYLGLYCERIN . DISODIUM EDTA . STEARALKONIUM HECTORITE . TOCOPHERYL ACETATE . MICA . HYDROXYETHYL UREA . SORBIC ACID . SODIUM LAUROYL GLUTAMATE . PROPYLENE CARBONATE . TOCOPHEROL . LYSINE . PERICHLAENA RICHARDII LEAF EXTRACT . CAMELLIA SINENSIS LEAF EXTRACT . MAGNESIUM CHLORIDE . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . ALGIN . ACACIA SENEGAL GUM . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . PALMITOYL DIPEPTIDE-5 DIAMINOHYDROXYBUTYRATE. ± / MAY CONTAIN/PEUT CONTENIR : CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES [M2374A].

Other information:

  • protect this product from excessive heat and direct sun.

Questions or comments?

Call 1-866-252-7467 (In the US) Monday-Friday 8 a.m. to 5 p.m.

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113 30ml (58668-6190-1)

Extra Comfort NoticeJar LabelTint 113

CLARINS EXTRA-COMFORT BROAD SPECTRUM SPF 15 SUNSCREEN TINT 113 
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-6190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE19 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARGAN OIL (UNII: 4V59G5UW9X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MICA (UNII: V8A1AW0880)  
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
SORBIC ACID (UNII: X045WJ989B)  
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LYSINE (UNII: K3Z4F929H6)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
ACACIA (UNII: 5C5403N26O)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACID (UNII: 1MGA33DQ5R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58668-6190-11 in 1 CARTON05/27/201410/31/2020
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/27/201410/31/2020
Labeler - Laboratoires Clarins S.A. (266317555)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Clarins S.A.266317555manufacture(58668-6190)

Revised: 1/2021
Document Id: b840e988-24e4-4343-e053-2a95a90ad15e
Set id: 529d4497-be81-4cc5-a85d-d0baa1a86c35
Version: 4
Effective Time: 20210106
 
Laboratoires Clarins S.A.