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

Clarins Broad Spectrum SPF 15 Sunscreen Care For Outdoor Sports by

Drug Labeling and Warnings

Clarins Broad Spectrum SPF 15 Sunscreen Care For Outdoor Sports by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active ingredients

AVOBENZONE  3%
HOMOSALATE  10%
OCTISALATE  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 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
  
• • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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 . OCTYLDODECANOL . BUTYLOCTYL SALICYLATE . POLYESTER-7 . NEOPENTYL GLYCOL DIHEPTANOATE . PARFUM/FRAGRANCE . TOCOPHERYL ACETATE . BENZYL SALICYLATE . ETHYLENE BRASSYLATE . LIMONENE . BUTYLPHENYL METHYLPROPIONAL . ALOE BARBADENSIS LEAF JUICE . BUTYLENE GLYCOL . GLYCERIN . AQUA/WATER/EAU . HEXYL CINNAMAL . CITRONELLOL . CASSIA ALATA LEAF EXTRACT . CITRIC ACID  POTASSIUM SORBATE .SODIUM BENZOATE.[S1234C]

Clarins Broad Spectrum SPF 15 Sunscreen Care Oil-Free Lotion Spray For Outdoor Sports 150ml (

58668-4061-1)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-4061
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	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-4061-1	1 in 1 CARTON	10/23/2013
1		150 mL in 1 BOTTLE, SPRAY; 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	10/23/2013

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-4061)