CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE by

Drug Labeling and Warnings

CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE 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 30 SUNSCREEN CARE OIL SPRAY

Active ingredients

AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 5%
OCTOCRYLENE 2.7%
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
• 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

C12-15 ALKYL BENZOATE - OCTYLDODECANOL - ALCOHOL - BUTYLOCTYL SALICYLATE - POLYESTER-7 - NEOPENTYL GLYCOL DIHEPTANOATE - CALOPHYLLUM INOPHYLLUM SEED OIL - PARFUM/FRAGRANCE - TRIISOSTEARIN - TOCOPHERYL ACETATE - BENZYL SALICYLATE - TOCOPHEROL - ETHYLENE BRASSYLATE - LIMONENE - BUTYLPHENYL METHYLPROPIONAL - ALOE BARBADENSIS LEAF JUICE - BUTYLENE GLYCOL - GLYCERIN - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - AQUA/WATER/EAU - HEXYL CINNAMAL - CITRONELLOL - CASSIA ALATA LEAF EXTRACT - PHENOXYETHANOL - PLATANUS OCCIDENTALIS BARK EXTRACT - CITRICACID - POTASSIUM SORBATE - SODIUM BENZOATE. [S2330A]

CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE OIL SPRAY 150ml (

58668-4561-1)

CLARINS

SUN CARE MULTI CELLULAR PROTECTION

CLARINS

BROAD SPECTRUM SPF 30

Sunscreen Care Oil Spray
For beautiful body and hair

WATER RESISTANT
(40 MINUTES)

e 150 mL  5 Fl. Oz.

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-4561
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TAMANU OIL (UNII: JT3LVK84A1)
TRIISOSTEARIN (UNII: 71503RH8KG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-4561-1	1 in 1 CARTON	07/11/2013
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	07/11/2013

Labeler - Laboratoires Clarins S.A. (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A.		266317555	manufacture(58668-4561)