SUPER CITY BLOCK- zinc oxide, octinoxate, titanium dioxide, and octisalate cream

SUPER CITY BLOCK by

Drug Labeling and Warnings

SUPER CITY BLOCK 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. For use on children under 6 months of age, consult a doctor. See enclosure.

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

ZINC OXIDE 8.80% OCTINOXATE 7.5% TITANIUM DIOXIDE 6.60% OCTISALATE 2.00%.

INGREDIENTS

WATER\AQUA\EAU TRIOCTYLDODECYL CITRATE BUTYLENE GLYCOL DIMETHICONE OCTYLDODECYL NEOPENTANOATE STEARETH-2 SILICA ALUMINUM STEARATE ROSA ROXBURGHII FRUIT EXTRACT CITRUS UNSHIU PEEL EXTRACT PORPHYRA YEZOENSIS (ALGAE) EXTRACT GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT SACCHAROMYCES LYSATE EXTRACT CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT BETULA ALBA (BIRCH) BARK EXTRACT HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT HELIANTHUS ANNULIS (SUNFLOWER) SEEDCAKE GENTIANA LUTEA (GENTIAN) ROOT EXTRACT YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE SODIUM RNA MAGNESIUM ASCORBYL PHOSPHATE DIPOTASSIUM GLYCYRRHIZATE TOCOPHERYL ACETATE PANTETHINE SQUALANE POLYGLYCERYL-6 POLYRICINOLEATE TRICAPRYLIN PROPYLENE GLYCOL DICAPRATE CHAMOMILLA RECUTTIA (MATRICARIA) HEXYLENE GLYCOL PEG/PPG-18/18 DIMETHICONE CAPRYLYL GLYCOL BARIUM SULFATE POLYETHYLENE XANTHAN GUM MAGNESIUM ALUMINUM SILICATE LECITHIN CETETH-2 PEG-40 STEARATE SODIUM STEARATE STEARETH-20 SORBITAN TRISTEARATE ISOPROPYL TITANIUM TRIISOSTEARATE CITRIC ACID DISODIUM EDTA BHT PHENOXYETHANOL MICA IRON OXIDES (CI 77491, CI 77492, CI77499) TITANIUM DIOXIDE (CI 77891) [ILN38498]

PRINCIPAL DISPLAY PANEL - 40 ml Carton

SUPER
CITY BLOCK
oil-free daily face protector

40SPF

CLINIQUE

1.4 FL.OZ.LIQ./
40 ml e

INGREDIENTS AND APPEARANCE

SUPER CITY BLOCK   SPF 40 OIL FREE DAILY FACE PROTECTOR
zinc oxide, octinoxate, titanium dioxide, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-942
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)	zinc oxide	8.8 mL  in 100 mL
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	7.5 mL  in 100 mL
titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP)	titanium dioxide	6.6 mL  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butylene glycol (UNII: 3XUS85K0RA)
dimethicone (UNII: 92RU3N3Y1O)
octyldodecyl neopentanoate (UNII: X8725R883T)
steareth-2 (UNII: V56DFE46J5)
silicon dioxide (UNII: ETJ7Z6XBU4)
aluminum stearate (UNII: U6XF9NP8HM)
angelica acutiloba root (UNII: 3W51R3EK30)
jujube fruit (UNII: G55HNL2C70)
rosa roxburghii fruit (UNII: CVT1AA87FF)
tangerine peel (UNII: JU3D414057)
porphyra yezoensis (UNII: D72A570T01)
paeonia suffruticosa root (UNII: 7M7E9A2C8J)
safflower (UNII: 4VBL71TY4Y)
glycyrrhiza glabra (UNII: 2788Z9758H)
paeonia lactiflora root (UNII: 3Z3866YW6P)
saccharomyces lysate (UNII: R85W246Z1C)
cucumber (UNII: YY7C30VXJT)
betula pubescens bark (UNII: 3R504894L9)
hordeum vulgare root (UNII: 790S39483Z)
rosemary (UNII: IJ67X351P9)
helianthus annuus seedcake (UNII: 482WYF7XLC)
gentiana lutea root (UNII: S72O3284MS)
yeast (UNII: 3NY3SM6B8U)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)
pantethine (UNII: 7K81IL792L)
glycerin (UNII: PDC6A3C0OX)
dextrose (UNII: IY9XDZ35W2)
squalane (UNII: GW89575KF9)
tricaprylin (UNII: 6P92858988)
propylene glycol dicaprate (UNII: U783H9JHWY)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
barium sulfate (UNII: 25BB7EKE2E)
high density polyethylene (UNII: UG00KM4WR7)
xanthan gum (UNII: TTV12P4NEE)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
ceteth-2 (UNII: 7H8VAM7778)
peg-40 stearate (UNII: ECU18C66Q7)
sodium stearate (UNII: QU7E2XA9TG)
steareth-20 (UNII: L0Q8IK9E08)
sorbitan tristearate (UNII: 6LUM696811)
citric acid monohydrate (UNII: 2968PHW8QP)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
fu ling (UNII: XH37TWY5O4)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMOMILE (UNII: FGL3685T2X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-942-01	1 in 1 CARTON
1		40 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2004

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