CITY BLOCK SHEER OIL FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25- titanium dioxide and zinc oxide cream

CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25 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

Titanium dioxide 7.3%
Zinc oxide 6.9%

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 trioctyldodecyl citrate butylene glycol cyclopentasiloxane dimethicone c12-15 alkyl benzoate steareth-2 stearyl heptanoate silica lecithin ammonium acryloyldimethyltaurate/vp copolymer gentiana lutea (gentian) root extract rosmarinus officinalis (rosemary) leaf extract hordeum vulgare (barley) extract\extrait d'orge betula alba (birch) bark extract cucumis sativus (cucumber) fruit extract laminaria saccharina extract saccharomyces lysate extract helianthus annuus (sunflower) seedcake sodium hyaluronate sorbitan tristearate linoleic acid polyquaternium-51 caprylyl methicone sorbitol sodium rna peg-40 stearate caprylyl glycol tocopheryl acetate phytantriol stearic acid hydrogenated lecithin cellulose magnesium ascorbyl phosphate stearyl dimethicone ascorbyl tocopheryl maleate nordihydroguaiaretic acid linolenic acid pantethine bisabolol ceteth-2 peg/ppg-18/18 dimethicone polyglyceryl-6 polyricinoleate steareth-20 isopropyl titanium triisostearate propylene glycol dicaprate sodium stearate nylon-12 citric acid aluminum hydroxide nylon-6 hexylene glycol xanthan gum disodium edta bht phenoxyethanol titanium dioxide (ci 77891) iron oxides (ci 77491, ci 77492, ci 77499) [iln37355]

Other information

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

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

sun protection

CITY BLOCK
SHEER
oil-free daily face protector

BROAD
SPECTRUM
25 SPF

CLINIQUE

1.4 FL.OZ.LIQ./
40 ml e

INGREDIENTS AND APPEARANCE

CITY BLOCK SHEER OIL FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	84.32 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	79.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
trioctyldodecyl citrate (UNII: 35X8CT063R)
butylene glycol (UNII: 3XUS85K0RA)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
steareth-2 (UNII: V56DFE46J5)
stearyl heptanoate (UNII: 2M4UGL1NCN)
silicon dioxide (UNII: ETJ7Z6XBU4)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
gentiana lutea root (UNII: S72O3284MS)
rosemary (UNII: IJ67X351P9)
barley (UNII: 5PWM7YLI7R)
cucumber (UNII: YY7C30VXJT)
saccharina latissima (UNII: 68CMP2MB55)
saccharomyces lysate (UNII: R85W246Z1C)
helianthus annuus seedcake (UNII: 482WYF7XLC)
hyaluronate sodium (UNII: YSE9PPT4TH)
sorbitan tristearate (UNII: 6LUM696811)
linoleic acid (UNII: 9KJL21T0QJ)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
sorbitol (UNII: 506T60A25R)
peg-40 stearate (UNII: ECU18C66Q7)
caprylyl glycol (UNII: 00YIU5438U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phytantriol (UNII: 8LVI07A72W)
stearic acid (UNII: 4ELV7Z65AP)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
powdered cellulose (UNII: SMD1X3XO9M)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
stearyl dimethicone (400 mpa.s at 50c) (UNII: R327X197HY)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
linolenic acid (UNII: 0RBV727H71)
pantethine (UNII: 7K81IL792L)
levomenol (UNII: 24WE03BX2T)
ceteth-2 (UNII: 7H8VAM7778)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
steareth-20 (UNII: L0Q8IK9E08)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
propylene glycol dicaprate (UNII: U783H9JHWY)
sodium stearate (UNII: QU7E2XA9TG)
nylon-12 (UNII: 446U8J075B)
citric acid monohydrate (UNII: 2968PHW8QP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
hexylene glycol (UNII: KEH0A3F75J)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-023-01	1 in 1 CARTON	12/19/2019
1		40 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	12/19/2019

Labeler - CLINIQUE LABORATORIES LLC. (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-023) , REPACK(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-023) , REPACK(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-023) , REPACK(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-023)