Drug facts

Active ingredients

AVOBENZONE 3%

HOMOSALATE 8%

OCTISALATE 4.5%

OCTOCRYLENE 6%

Purpose

Sunscreen

Uses:

• helps prevent sunburn • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun
Directions

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

• 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 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 sun screen if swimming or sweating Sun Protection Measures.

Inactive ingredients:

AQUA/WATER/EAU . DICAPRYLYL CARBONATE . GLYCERIN . BUTYLOCTYL SALICYLATE . PENTYLENE GLYCOL . CETEARYL ALCOHOL . ASCORBYL GLUCOSIDE . POTASSIUM CETYL PHOSPHATE . SQUALANE . DIMETHICONE . PARFUM/FRAGRANCE . BUTYLENE GLYCOL . CETEARYL GLUCOSIDE . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER . SODIUM HYDROXIDE . XYLITYLGLUCOSIDE . HYDROXYACETOPHENONE . SODIUM CITRATE . ANHYDROXYLITOL . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . XANTHAN GUM . CI 77891/TITANIUM DIOXIDE . CAPRYLIC/CAPRIC TRIGLYCERIDE . SYNTHETIC FLUORPHLOGOPITE . DIMETHICONOL . XYLITOL . DISODIUM EDTA . SODIUM LACTATE . SUCROSE PALMITATE . GLUCOSE . CARBOMER . CITRIC ACID . HARUNGANA MADAGASCARIENSIS EXTRACT . MARRUBIUM VULGARE EXTRACT . COCO-GLUCOSIDE . BALANITES ROXBURGHII SEED OIL . GLYCERYL LINOLEATE . PHENETHYL ALCOHOL . FURCELLARIA LUMBRICALIS EXTRACT . PANCRATIUM MARITIMUM EXTRACT . TIN OXIDE . ULEX EUROPAEUS LEAF/ROOT/STEM EXTRACT . TOCOPHEROL . POTASSIUM SORBATE . PROPANEDIOL . PECTIN . SODIUM HYALURONATE . GUAR HYDROXYPROPYLTRIMO- NIUM CHLORIDE . CI 14700/RED 4 . PALMITOYL TRIPEPTIDE-1 . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . MARIS SAL/SEA SALT/SEL MARIN . PALMITOYL TETRAPEPTIDE-7. [S4041A]

Other information:

• protect this product from excessive heat and direct sun

Questions or comments?

Call 1-866-325-2746 Monday-Friday 9 a.m. to 6:30 p.m. ET

Package Labeling:

Outer Package Inner Package Box Box2

CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58668-9920
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
XYLITOL (UNII: VCQ006KQ1E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HOREHOUND (UNII: K08036XEJV)
COCO GLUCOSIDE (UNII: ICS790225B)
BALANITES ROXBURGHII SEED OIL (UNII: CZ67V4ZW0I)
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
FURCELLERAN (UNII: 30QS0PF14U)
STANNIC OXIDE (UNII: KM7N50LOS6)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
PECTIN (UNII: 89NA02M4RX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58668-9920-1	50 mL in 1 JAR; Type 0: Not a Combination Product	04/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/01/2023

Labeler - Laboratoires Clarins (266317555)

CLARINS – MULTI-INTENSIVE JOUR / SUPER RESTORATIVE DAY CREAM BROAD SPECTRUM – SPF 15 - SUNSCREEN