CLARINS HYDRAQUENCH NORMAL TO COMBINATION SKIN BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, homosalate, octocrylene lotion

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

Drug Labeling and Warnings

CLARINS HydraQuench Normal to Combination 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.

Inactive ingredients:

AQUA/WATER/EAU . C12-15 ALKYL BENZOATE . GLYCERIN . BUTYLOCTYL SALICYLATE . CETEARYL ALCOHOL . TAPIOCA STARCH . HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER . POTASSIUM CETYL PHOSPHATE . PARFUM/FRAGRANCE . CAPRYLYL GLYCOL . CETEARYL GLUCOSIDE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN .TOCOPHERYL ACETATE . XANTHAN GUM . BUTYLENE GLYCOL . SODIUM DEHYDROACETATE . TOCOPHEROL . SODIUM HYALURONATE . SODIUM PCA . 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 . EPILOBIUM FLEISCHERI EXTRACT . PUNICA GRANATUM BARK EXTRACT . CAMELLIA SINENSIS LEAF EXTRACT .POTASSIUM SORBATE . RHODIOLA ROSEA ROOT EXTRACT . SODIUM LAURYL SULFATE. [S2435A]

HydraQuench Lotion SPF 15 Normal to combination skin

This lightweight, non-oily lotion with UV protection was specifically formulated to promote softer, more radiant skin for those with normal to combination skin. Katafray bark extract and hyaluronic acid help maintain an optimal level of hydration.  Extracts of Alpine willow herb and pomegranate promote a matte, fresh appearance. Anti-pollution. 2 patent applications (WO).  Dermatologist tested, non-comedogenic.

Package Insert

HydraQuench Lotion SPF 15
Normal to combination skin
This lightweight, non-oily lotion with UV protection is a "must use" daily moisturizer to help promote balanced hydration. Its lightweight texture helps maintain softer, more radiant skin for those with normal to combination skin while helping to minimize shine caused by heat or humidity.

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 becomes balanced, its texture more refined
To assure a fresh, matte appearance for those with combination skin or inwarm, humid climates, thismoisturizer contains Alpine willow herb extract which helps regulate production and pomegranate extract which promotes tighter pores.  An added bonus, this lotion helps protect the skin from the harmful effects of the sun and the environment thanks to anti-UV filters and Clarins exclusive anti-pollution complex.

Apply in the morning to the face and neck.

PRINCIPAL DISPLAY PANEL

CLARINS  SIONS MULTI-HYDRATANTS HYDRATING CARE    CLARINS PARIS  BROAD SPECTRUM SPF 15 - Sunscreen   HydraQuench Lotion  Normal to combination skin  e 50 mL    1.6 Fl. Oz.   CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France Made in France - Brevets (WO) "CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients." Jacques Courtin Clarins

Product Labels

INGREDIENTS AND APPEARANCE

CLARINS HYDRAQUENCH NORMAL TO COMBINATION SKIN BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, homosalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-1140
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
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)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
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: 58668-1140-1	1 in 1 CARTON	10/03/2012
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	10/03/2012

Labeler - Laboratoires Clarins S.A (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A		266317555	manufacture(58668-1140)