CLARINS - EXTRA-FIRMING JOUR SPF 15 - WRINKLE, FIRMING DAY ALL SKIN TYPES - BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, homosalate, octocrylene cream

CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen 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 9% 
OCTOCRYLENE 6.5%

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 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

Inactive ingredients:

AQUA/WATER/EAU . GLYCERIN . BUTYLOCTYL SALICYLATE . BUTYROSPERMUM PARKII (SHEA) BUTTER . DIMETHICONE . C12-15 ALKYL BENZOATE . CETEARYL ALCOHOL . METHYL METHACRYLATE CROSSPOLYMER . POTASSIUM CETYL PHOSPHATE . PARFUM/FRAGRANCE .
CETEARYL GLUCOSIDE . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . PHENOXYETHANOL . BUTYLENE GLYCOL . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER . CAPRYLYL GLYCOL . TROMETHAMINE . AVENA SATIVA (OAT) KERNEL EXTRACT . DISODIUM EDTA .
TOCOPHERYL ACETATE . XANTHAN GUM . DIMETHICONOL . TOCOPHEROL . ANIGOZANTHOS FLAVIDUS EXTRACT . CAPRYLIC/CAPRIC TRIGLYCERIDE . BETAINE . SILICA . SORBITOL . DIOSPYROS MESPILIFORMIS LEAF EXTRACT . MALTODEXTRIN . SANICULA EUROPAEA EXTRACT
. SODIUM BENZOATE . KALANCHOE PINNATA LEAF EXTRACT . BALANITES ROXBURGHII SEED OIL . MITRACARPUS SCABER EXTRACT . CITRIC ACID . MALPIGHIA EMARGINATA (ACEROLA) SEED EXTRACT . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT
.
FURCELLARIA LUMBRICALIS EXTRACT
.
CI 15985/YELLOW 6
.
POTASSIUM SORBATE
.
MARIS SAL/SEA SALT/SEL MARIN. [S3095A]

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.

Package Labeling:

INGREDIENTS AND APPEARANCE

CLARINS - EXTRA-FIRMING JOUR SPF 15 - WRINKLE, FIRMING DAY ALL SKIN TYPES - BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, homosalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-9918
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	90 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TROMETHAMINE (UNII: 023C2WHX2V)
OAT (UNII: Z6J799EAJK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BETAINE (UNII: 3SCV180C9W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
DIOSPYROS MESPILIFORMIS LEAF (UNII: 0R6X2JX6J1)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
KALANCHOE PINNATA LEAF (UNII: 3R963LO08T)
BALANITES ROXBURGHII SEED OIL (UNII: CZ67V4ZW0I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALPIGHIA EMARGINATA SEED (UNII: 1X7L93686M)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
FURCELLERAN (UNII: 30QS0PF14U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-9918-1	1 in 1 CARTON	10/05/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 58668-9918-2	1 in 1 CARTON	10/05/2017
2		50 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 58668-9918-3	1 in 1 CARTON	10/05/2017
3		15 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 58668-9918-4	1 in 1 CARTON	10/05/2017
4		5 mL in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 58668-9918-5	1 in 1 CARTON	10/05/2017
5		2 mL in 1 BAG; Type 0: Not a Combination Product
6	NDC: 58668-9918-6	1 in 1 CARTON	10/26/2017
6		2 mL in 1 BAG; 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	10/05/2017

Labeler - Laboratoires Clarins (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins		266317555	manufacture(58668-9918)