CLARINS HYDRAQUENCH NORMAL TO DRY SKIN BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, homosalate, octocrylene cream

CLARINS HydraQuench Normal to Dry Skin Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

CLARINS HydraQuench Normal to Dry Skin Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

AVOBENZONE 3% . HOMOSALATE 5% . OCTOCRYLENE 2.7%

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 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.

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.

HydraQuench Cream SPF 15 - Normal to dry skin

This lightweight cream offers effective UV protection and was specifically formulated to promote softer, more radiant skin. Katafray bark extract and hyaluronic acid help maintain an optimal level of hydration. Anti-pollution. 2 patent applications (WO). Dermatologist tested, non-comedogenic.

Inactive ingredients:

AQUA/WATER/EAU . C12-15 ALKYL BENZOATE . GLYCERIN . BUTYLOCTYL SALICYLATE . BUTYROSPERMUM PARKII (SHEA) BUTTER .CETEARYL ALCOHOL .DIMETHICONE .TAPIOCA STARCH .POTASSIUM CETYL PHOSPHATE .HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER . CETEARYL GLUCOSIDE . PARFUM/FRAGRANCE . ISOHEXADECANE . CAPRYLYL GLYCOL . DISODIUM EDTA .TOCOPHERYL ACETATE . XANTHAN GUM . POLYSORBATE 60 . SODIUM DEHYDROACETATE . BUTYLENE GLYCOL . TOCOPHEROL . SODIUM HYALURONATE . SODIUM PCA . SORBITAN ISOSTEARATE . ALCOHOL . PHENOXYETHANOL . PENTYLENE GLYCOL . BIOSACCHARIDE GUM-4 . CEDRELOPSIS GREVEI BARK EXTRACT . THERMUS THERMOPHILLUS FERMENT . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . PYRUS SORBUS BUD EXTRACT . CAMELLIA SINENSIS LEAF EXTRACT . POTASSIUM SORBATE . RHODIOLA ROSEA ROOT EXTRACT . SODIUM LAURYL SULFATE. [S2436A]

Package Insert

HydraQuench Cream SPF 15  Normal to dry skin
This cream with UV protection is a "must use" daily moisturizer to help promote soft, more radiant skin for those with normal to dry skin.  Its light weight texture promotes balanced hydration and leaves an invisible layer of well-being on the skin's surface.

Your skin is continuously hydrated
Exclusive to Clarins, katafray bark extract enhances the production of natural moisturization factors.  Hyaluronic acid helps maintain moisture reserves within the skin layers.

Your skin looks healthy and radiant
Sorbier bud extract targets skin's microcirculation and helps restore a fresher-looking appearance.  An added bonus, this cream helps protect the skin from harmful effects of the sun and environment thanks to anti-UV filters and Clarins exclusive anti-pollution complex.

Apply in the morning to the face and neck.

PRINCIPAL DISPLAY PANEL

SIONS MULTI-HYDRANTS HYDRATING CARE   CLARINS PARIS   HydraQuench Cream Normal to dry skin   BROAD SPECTRUM - SPF 15 - Sunscreen    e50mL    1.7 Oz. Net Wt.   WITH PLANT EXTRACTS   CLARINS PARIS - 92200 Neuilly - 95300 Pontoise - France Made in France - Brevets (WO) et marques déposés Patent applications (WO)  www.clarins.com   "CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients." Jacques Courtin Clarins

Product Labels

INGREDIENTS AND APPEARANCE

CLARINS HYDRAQUENCH NORMAL TO DRY SKIN BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, homosalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-1139
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	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ISOHEXADECANE (UNII: 918X1OUF1E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CEDRELOPSIS GREVEI BARK (UNII: RT338M820U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-1139-1	1 in 1 CARTON	10/01/2010
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/01/2010

Labeler - Laboratoires Clarins S.A (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A		266317555	manufacture(58668-1139)