SPF 50- oxybenzone, octisalate, homosalate, avobenzone, and octocrylene cream

SPF 50 by

Drug Labeling and Warnings

SPF 50 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC., ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TO USE

Apply liberally before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply frequently, and after towel drying, swimming or perspiring.

WARNING

For external use only.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help right away.

ACTIVE INGREDIENTS

OXYBENZONE 5.0%, OCTISALATE 5.0%, HOMOSALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 2.7%.

INGREDIENTS

WATER METHYL TRIMETHICONE BUTYLENE GLYCOL BUTYLOCTYL SALICYLATE NEOPENTYL GLYCOL DIHEPTANOATE BUTYROSPERMUM PARKII (SHEA BUTTER) PEG-100 STEARATE SILICA DI-PENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE DIMETHICONE GLYCERYL STEARATE LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT PERILLA OCYMOIDES LEAF EXTRACT PLANKTON EXTRACT CAFFEINE POTASSIUM CETYL PHOSPHATE SUCROSE STYRENE/ACRYLATES COPOLYMER C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER CETYL ALCOHOL VP/EICOSENE COPOLYMER ETHYLHEXYLGLYCERIN AMMONIUM ACRYLOYLDIMETHYL TAURATE/VP COPOLYMER PEG-8 LAURATE SODIUM RNA LECITHIN PROPYL GALLATE ARGININE FERULATE TOCOPHERYL ACETATE CAPRYLYL GLYCOL ASCORBYL TOCOPHERYL MALEATE STEARIC ACID XANTHAN GUM HEXYLENE GLYCOL NORDIHYDROGUAIARETIC ACID DISODIUM EDTA PHENOXYETHANOL MICA SODIUM DEHYDROACETATE [ILN37123]

SPL UNCLASSIFIED SECTION

CLINIQUE LABS., DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

CLINIQUE
SPF
50
with
SolarSmart

UVA UVB
advanced
protection

face cream

1.7 FL.OZ.
50 ml e

INGREDIENTS AND APPEARANCE

SPF 50   WITH SOLAR SMART
oxybenzone, octisalate, homosalate, avobenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-717
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y)	oxybenzone	5 mL  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	5 mL  in 100 mL
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	5 mL  in 100 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	3 mL  in 100 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	2.7 mL  in 100 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)
dimethicone (UNII: 92RU3N3Y1O)
glyceryl monostearate (UNII: 230OU9XXE4)
rosemary (UNII: IJ67X351P9)
perilla frutescens leaf (UNII: T4L5881Y68)
caffeine (UNII: 3G6A5W338E)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
sucrose (UNII: C151H8M554)
cetyl alcohol (UNII: 936JST6JCN)
ethylhexylglycerin (UNII: 147D247K3P)
peg-8 laurate (UNII: 762O8IWA10)
propyl gallate (UNII: 8D4SNN7V92)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
caprylyl glycol (UNII: 00YIU5438U)
stearic acid (UNII: 4ELV7Z65AP)
xanthan gum (UNII: TTV12P4NEE)
hexylene glycol (UNII: KEH0A3F75J)
masoprocol (UNII: 7BO8G1BYQU)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
sodium dehydroacetate (UNII: 8W46YN971G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-717-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2009

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE

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

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE