SUPER CITY BLOCK BB CUSHION COMPACT BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide liquid

SUPER CITY BLOCK BB CUSHION COMPACT BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

SUPER CITY BLOCK BB CUSHION COMPACT BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V, LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD., NIPPON SHIKIZAI INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 7.6%

Zinc Oxide 5.1%

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 dimethicone butyloctyl salicylate isononyl isononanoate octyldodecyl neopentanoate butylene glycol phenyl trimethicone lauryl peg-9 polydimethylsiloxyethyl dimethicone diethylhexyl succinate methyl trimethicone silica dimethicone silylate tocopheryl acetate magnesium sulfate dipentaerythrityl tri-polyhydroxystearate lens esculenta (lentil) fruit extract pyrus malus (apple) fruit extract litchi chinensis seed extract palmaria palmata extract laminaria saccharina extract porphyra yezoensis (algae) extract citrullus vulgaris (watermelon) fruit extract silk powder\serica\poudre de soie acetyl hexapeptide-8 caprylyl methicone tourmaline caffeine sodium lactate thermus thermophillus ferment cetyl peg/ppg-10/1 dimethicone ascorbyl glucoside hydrolyzed wheat protein/pvp crosspolymer triethoxycaprylylsilane caprylyl glycol sodium pca polyhydroxystearic acid glycerin sodium hyaluronate dimethicone crosspolymer-3 dipropylene glycol laureth-4 dimethicone/peg-10/15 crosspolymer dextrin sodium benzoate pentylene glycol citric acid phenoxyethanol chlorphenesin [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] [iln42060]

Other information

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

PRINCIPAL DISPLAY PANEL - 12 g Compact Carton

CLINIQUE

super city block BB
cushion compact
broad spectrum SPF 50

POIDS NET WT. 0.4 OZ./12 g e

INGREDIENTS AND APPEARANCE

SUPER CITY BLOCK BB CUSHION COMPACT BROAD SPECTRUM SPF 50 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7.6 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	5.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
APPLE (UNII: B423VGH5S9)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
DULSE (UNII: 7832HOY4ZQ)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
PORPHYRA YEZOENSIS (UNII: D72A570T01)
WATERMELON (UNII: 231473QB6R)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CAFFEINE (UNII: 3G6A5W338E)
SODIUM LACTATE (UNII: TU7HW0W0QT)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LAURETH-4 (UNII: 6HQ855798J)
ICODEXTRIN (UNII: 2NX48Z0A9G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-047-01	1 in 1 CARTON	12/15/2015
1		12 g in 1 CASE; 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	12/15/2015

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-047) , REPACK(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V		370151326	MANUFACTURE(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-047) , REPACK(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-047) , REPACK(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-047)

Establishment
Name	Address	ID/FEI	Business Operations
NIPPON SHIKIZAI INC		694869178	MANUFACTURE(49527-047)