CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN- homosalate, octisalate, and avobenzone stick

CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN by

Drug Labeling and Warnings

CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., Len-Ron Manufacturing Division of Aramis Inc., NORTHTEC INC, PADC 1, NORTHTEC PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3.0%
Homosalate 5.0%
Octisalate 5.0%

Purpose

Sunscreen

Use

helps prevent sunburn

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

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• 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 a Broad Spectrum SPF value 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
• children under 6 months of age: ask a doctor

Inactive ingredients

microcrystalline wax\cera microcristallina\cire microcristalline jojoba esters phenyl trimethicone simmondsia chinensis (jojoba) butter cetyl ricinoleate butyloctyl salicylate polyester-8 beeswax\cera alba\cire d'abeille polyethylene tocopheryl acetate vp/eicosene copolymer tocopherol [iln35001]

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 6 g Cylinder Carton

CLINIQUE

broad
spectrum
SPF 45
sunscreen

UVA | UVB
PROTECTION

targeted
protection
stick

NET WT. .21 OZ.
6g e

INGREDIENTS AND APPEARANCE

CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN 
homosalate, octisalate, and avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
microcrystalline wax (UNII: XOF597Q3KY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
jojoba butter (UNII: XIA46H803R)
cetyl ricinoleate (UNII: 1P677500YD)
butyloctyl salicylate (UNII: 2EH13UN8D3)
yellow wax (UNII: 2ZA36H0S2V)
high density polyethylene (UNII: UG00KM4WR7)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-041-01	1 in 1 CARTON	12/01/2008
1		6 g in 1 CYLINDER; 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	12/01/2008

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-041) , REPACK(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-041) , REPACK(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-041) , REPACK(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-041)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-041)