CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED SUNSCREEN MULTI-PROTECTION- homosalate, octocrylene, oxybenzone, titanium dioxide liquid

CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-Protection by

Drug Labeling and Warnings

CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-Protection by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A., Accra Pac, Inc. dba Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

HOMOSALATE 4%
OCTOCRYLENE 4%
OXYBENZONE 1.5%
TITANIUM DIOXIDE 10.9%

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, DIMETHICONE, ALCOHOL, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, NYLON-12, PEG-12 DIMETHICONE, SODIUM CHLORIDE, PHENOXYETHANOL, PARFUM/FRAGRANCE, PEG/PPG-18/18DIMETHICONE, GLYCERIN, .ETHYLHEXYL GLYCERIN, TOCOPHERYL ACETATE, DISODIUM EDTA, SANICULA EUROPAEA EXTRACT, BUTYLENE GLYCOL, 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. [S2705A]

Laboratoires Clarins S.A.

Sunscreen Multi-Protection
Broad Spectrum SPF 50 Oil-free

Multi-protection against the harmful effects of UV rays, free radicals and pollution for everlasting youthful, luminous and even skin. The ultra-lightweight texture is ideal for application over your regular day care and is resistant to urban life.

Reinforced anti-pollution protection

The exclusive Clarins Anti-Pollution Complex is combined with powerful antioxidant extracts of organic Alpine sanicle and cantaloupemelon, known for theirmulti-level action*.Acombination which protects skin and prevents premature ageing. *In vitro tests.

Dermatologist and ophthalmologist tested, noncomedogenic.

CLARINS PARIS - 75017 Paris    95300 Pontoise - France    Made in France

PRINCIPAL DISPLAY PANEL

CLARINS PARIS UV PLUS ANTI-POLLUTION Ecran Multi-Protection BROAD SPECTRUM SPF 50 Oil-free Sunscreen Multi-Protection 50 mL 1.7 Fl. Oz.

Product Labels

INGREDIENTS AND APPEARANCE

CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED SUNSCREEN MULTI-PROTECTION 
homosalate, octocrylene, oxybenzone, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-2951
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	150 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	109 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
NYLON-12 (UNII: 446U8J075B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
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: 58668-2951-1	1 in 1 CARTON	09/16/2014
1		50 mL in 1 CONTAINER; 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	09/16/2014

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-2951)