CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN FOR SUN-SENSITIVE AREAS- titanium dioxide, zinc oxide stick

Clarins Broad Spectrum SPF 30 Sunscreen for Sun-Sensitive Areas by

Drug Labeling and Warnings

Clarins Broad Spectrum SPF 30 Sunscreen for Sun-Sensitive Areas by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins S.A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

TITANIUM DIOXIDE 9.7%
ZINC OXIDE 3.8%

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

if rash occurs.

Keep out of reach of children.

If product is swallowed, get me dical 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.  Spend ing time in the sun in creases 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 sun screen 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:

RICINUS COMMUNIS (CASTOR) SEED OIL . OCTYLDODECANOL . CAPRYLIC/CAPRIC TRIGLYCERIDE . HELIANTHUS ANNUUS (SUN FLOWER) SEED WAX . HYDROGENATED POLYISOBUTENE . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . BUTYROSPERMUM PARKII (SHEA) BUTTER . COPER NICIA CERIFERA CERA(COPERNICIA CERI FERA (CARNAUBA) WAX/CIRE DE CARNAUBA OZOKERITE . POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE . POLYGLYCERYL-3 DIISOSTEARATE . MANGIFERA INDICA (MANGO) SEED OIL . ALUMINA . STEARIC ACID . TOCOPHERYL ACETATE . PARFUM/FRAGRANCE . DIETHYLHEXYL ADIPATE . TOCOPHEROL . CENTELLA ASIATICA EXTRACT, BHT, CITRIC ACID. [S2215A]

Sunscreen Stick

For Sun-Sensitive Areas 100% mineral screen SPF 30
Comfortable protection for sun-sensitive areas like the nose, lips and ears. Ideal for water sports, winter skiing and intense sunlight. Apply well before sun exposure. Renew application at least every two hours.
Dermatologist tested.

PRINCIPAL DISPLAY PANEL

CLARINS  SUN CARE MULTI CELLULAR PROTECTION     CLARINS PARIS  BROAD SPECTRUM SPF 15  Sunscreen Stick For Sun-Sensitive Areas    e 8g  0.2 Oz. Net Wt.   "CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients." Jacques Courtin Clarins

Product Labels

INGREDIENTS AND APPEARANCE

CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN FOR SUN-SENSITIVE AREAS 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58668-4021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CERESIN (UNII: Q1LS2UJO3A)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
MANGO SEED OIL (UNII: K8LOR30915)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)
TOCOPHEROL (UNII: R0ZB2556P8)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58668-4021-1	1 in 1 CARTON	09/27/2012
1		8 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/27/2012

Labeler - Laboratoires Clarins S.A (266317555)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Clarins S.A		266317555	manufacture(58668-4021)