CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN CARE FOR OUTDOOR SPORTS- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone spray
Laboratoires Clarins S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CLARINS Broad Spectrum SPF 15 Sunscreen Care Oil-Free Lotion Spray For Outdoor Sports

Active ingredients

AVOBENZONE 3%
HOMOSALTE 8%
OCTINOXATE 7.5%
OCTISALATE 5%
OCTOCRYLENE 2%
OXYBENZONE 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 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 Protect ion 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

ALCOHOL . PARFUM/FRAGRANCE . TOCOPHERYL ACETATE . GLYCERIN . HEXYL CINNAMAL . AQUA/WATER/EAU . HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE . LINALOOL . LIMONENE . AMYL CINNAMAL . ALOE BARBADENSIS LEAF JUICE . BUTYLENE GLYCOL . BHT . COUMARIN . CITRONELLOL . ALPHA-ISOMETHYL IONONE . GERANIOL . CI 15985/YELLOW 6 . CASSIA ALATA LEAF EXTRACT . PHENOXYETHANOL . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S1234A]

CLARINS:

effective, serious treatments, ensuring maximum results with the highest quality ingredients. Jacques Courtin Clarins

www.clarins.com CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France Made in France - Brevet (FR) Patent application (FR) WITH PLANT EXTRACTS

Sunscreen Care Oil-Free Lotion Spray For outdoor sports SPF 15

Sun care recommended for outdoor sports thanks to the ultra-fine diffusion of its spray on formula. Ideal for men.
• Invigorating, colourless lotion.
• Helps protect and hydrate skin thanks to senna, plane tree and aloe vera extracts. Ensures a beautiful, healthy-looking glow. Note. This product contains alcohol. Do not use on children. Dermatologist tested.

SUN CARE MULTI CELLULAR PROTECTION CLARINS PARIS BROAD SPECTRUM SPF 15 Sunscreen Care Oil-Free Lotion Spray For outdoor sports e 150 mL 5 Fl. Oz.

CLARINS Broad Spectrum SPF 15 Sunscreen Care Oil-Free Lotion Spray For Outdoor Sports 150ml (58668-4571-1)

Inner Label Outer Label

CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN CARE FOR OUTDOOR SPORTS
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58668-4571
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
WATER (UNII: 059QF0KO0R)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
COUMARIN (UNII: A4VZ22K1WT)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PLATANUS OCCIDENTALIS BARK (UNII: 85RMN3QGSE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58668-4571-1	1 in 1 CARTON	02/28/2013	12/31/2016
1		150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/28/2013	12/31/2016

Labeler - Laboratoires Clarins S.A. (266317555)

Name	Address	ID/FEI	Business Operations
Establishment
Laboratoires Clarins S.A.		266317555	manufacture(58668-4571)

Revised: 12/2016

Document Id: 44bee321-ea5b-4843-e054-00144ff88e88

Set id: 87e27cf8-123a-43a7-9db8-042cbd062988

Version: 3

Effective Time: 20161228

Laboratoires Clarins S.A.