CLARINS UV PLUS ANTI-POLLUTION B.S. SPF 50, SUNSCREEN MULTI-PROTECTION TINT MEDIUM- homosalate,octocrylene,oxybenzone,titanium dioxide liquid

Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium by

Drug Labeling and Warnings

Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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Active ingredients

HOMOSALATE 4%

OCTOCRYLENE 4%

OXYBENZONE 1.5%

TITANIUM DIOXIDE 8.4%

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, 8a.m. to 5 p.m.

Inactive ingredients:

DIMETHICONE, AQUA/WATER/EAU, ALCOHOL, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, PEG/PPG-18/18 DIMETHICONE, NYLON-12, PEG-12 DIMETHICONE, SODIUM CHLORIDE, PHENOXYETHANOL, PARFUM/FRAGRANCE, GLYCERIN, ETHYLHEXYL GLYCERIN, TOCOPHERYL ACETATE, DISODIUM EDTA, SANICULA EUROPAEA EXTRACT, BUTYLENE GLYCOL, SODIUM LAUROYL GLUTAMATE, LYSINE, MAGNESIUM CHLORIDE, SODIUM HYALURONATE, HYDROXYPROPYLTRIMONIUM MALTODEXTRIN CROSSPOLYMER, THERMUS THERMOPHILLUS FERMENT, LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT, RIBES NIGRUM (BLACK CURRANT) BUD EXTRACT, POTASSIUM SORBATE, CITRIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, CUCUMIS MELO (MELON) FRUIT EXTRACT, SODIUM LAURYL SULFATE, +/- MAY CONTAIN: CI77891/TITANIUM DIOXIDE, CI77491/ CI77492/ CI77499 / IRON OXIDES. [S27034]

Package Labeling:

INGREDIENTS AND APPEARANCE

CLARINS UV PLUS ANTI-POLLUTION B.S. SPF 50, SUNSCREEN MULTI-PROTECTION TINT MEDIUM 
homosalate,octocrylene,oxybenzone,titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-1619
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	15 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	84 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SANICULA EUROPAEA LEAF (UNII: JYZ6110L9I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
RIBES NIGRUM FLOWER BUD (UNII: VYH9Y9BCCP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MUSKMELON (UNII: ZV095H5633)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-1619-1	1 in 1 CARTON	09/22/2015
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 not final	part352	09/22/2015

Labeler - Laboratoires Clarins (266317555)