CLARINS BROAD SPECTRUM SPF 50 DRY TOUCH FACIAL SUNSCREEN ENRICHED WITH ANTIOXIDANTS PREVENTS SUN INDUCED AGE SPOTS- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

CLARINS BROAD SPECTRUM SPF 50 Dry Touch Facial Sunscreen Enriched with antioxidants Prevents sun induced age spots by

Drug Labeling and Warnings

CLARINS BROAD SPECTRUM SPF 50 Dry Touch Facial Sunscreen Enriched with antioxidants Prevents sun induced age spots by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

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 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

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 . DIPROPYLENE GLYCOL DIBENZOATE . BUTYLENE GLYCOL . ALCOHOL . ALUMINUM STARCH OCTENYLSUCCINATE . ALOE BARBADENSIS LEAF JUICE . PPG-15 STEARYL ETHER BENZOATE . MANNITOL . CETEARYL ALCOHOL . PARFUM/ FRAGRANCE . POTASSIUM CETYL PHOSPHATE . GLYCERIN . PHENOXYETHANOL . ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER . CETEARYL GLUCOSIDE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . XANTHAN GUM . TROMETHAMINE . TOCOPHEROL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE . BENZYL SALICYLATE . LIMONENE . BUTYLPHENYL METHYLPROPIONAL . HEXYL CINNAMAL . CITRONELLOL. [S1762A]

Package Labeling: (

58668-3320-0)

Package Labeling: (

58668-3320-2)

Package Labeling: (

58668-3320-1)

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 50 DRY TOUCH FACIAL SUNSCREEN ENRICHED WITH ANTIOXIDANTS PREVENTS SUN INDUCED AGE SPOTS 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-3320
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	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
MANNITOL (UNII: 3OWL53L36A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
TROMETHAMINE (UNII: 023C2WHX2V)
TOCOPHEROL (UNII: R0ZB2556P8)
PEA (UNII: W4X7H8GYFM)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-3320-0	1 in 1 CARTON	02/01/2019
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58668-3320-1	1 in 1 CARTON	02/01/2019
2		5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 58668-3320-2	1 in 1 CARTON	02/01/2019
3		50 mL in 1 TUBE; 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	02/01/2019

Labeler - Laboratoires Clarins (266317555)