CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART by

Drug Labeling and Warnings

CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. 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%
Octocrylene 2.7%
Oxybenzone 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

water\aqua\eau methyl trimethicone butylene glycol butyloctyl salicylate neopentyl glycol diheptanoate butyrospermum parkii (shea butter) peg-100 stearate silica dipentaerythrityl tri-polyhydroxystearate lauryl peg-9 polydimethylsiloxyethyl dimethicone dimethicone glyceryl stearate laurdimonium hydroxypropyl hydrolyzed soy protein rosmarinus officinalis (rosemary) extract perilla ocymoides leaf extract caffeine potassium cetyl phosphate sucrose styrene/acrylates copolymer c30-38 olefin/isopropyl maleate/ma copolymer cetyl alcohol vp/eicosene copolymer ethylhexylglycerin ammonium acryloyldimethyltaurate/vp copolymer peg-8 laurate sodium rna lecithin arginine ferulate tocopheryl acetate caprylyl glycol propyl gallate ascorbyl tocopheryl maleate stearic acid xanthan gum hexylene glycol nordihydroguaiaretic acid disodium edta phenoxyethanol mica sodium dehydroacetate [iln37121]

Other information

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

PRINCIPAL DISPLAY PANEL - 150 ml Tube Carton

CLINIQUE

broad
spectrum
SPF 50
sunscreen
with
SolarSmart

UVA UVB
PROTECTION

body cream

5 FL. OZ.
150 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0309 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0515 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0515 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0278 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0515 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methyl trimethicone (UNII: S73ZQI0GXM)
butylene glycol (UNII: 3XUS85K0RA)
butyloctyl salicylate (UNII: 2EH13UN8D3)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
shea butter (UNII: K49155WL9Y)
peg-100 stearate (UNII: YD01N1999R)
silicon dioxide (UNII: ETJ7Z6XBU4)
dipentaerythrityl tri-polyhydroxystearate (UNII: D21K655H52)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
dimethicone (UNII: 92RU3N3Y1O)
glyceryl monostearate (UNII: 230OU9XXE4)
rosemary (UNII: IJ67X351P9)
caffeine (UNII: 3G6A5W338E)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
sucrose (UNII: C151H8M554)
cetyl alcohol (UNII: 936JST6JCN)
ethylhexylglycerin (UNII: 147D247K3P)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
peg-8 laurate (UNII: 762O8IWA10)
arginine ferulate (UNII: 0774Y45BEE)
caprylyl glycol (UNII: 00YIU5438U)
propyl gallate (UNII: 8D4SNN7V92)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
stearic acid (UNII: 4ELV7Z65AP)
xanthan gum (UNII: TTV12P4NEE)
hexylene glycol (UNII: KEH0A3F75J)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
sodium dehydroacetate (UNII: 8W46YN971G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-069-01	1 in 1 CARTON	06/01/2011
1		150 mL in 1 TUBE; 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	06/01/2011

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-069) , REPACK(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-069) , REPACK(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-069) , REPACK(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-069)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-069)