CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15- octinoxate, octisalate, titanium dioxide, and zinc oxide liquid

CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15 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

Octinoxate 7.0%
Octisalate 4.5%
Titanium Dioxide 7.8%
Zinc Oxide 1.9%

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 sunscren 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. Spening time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary 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

dimethiconewater\aqua\eauvinyl dimethicone/methicone silsesquioxane crosspolymerpeg-10 dimethiconebutylene glycolphenyl trimethiconeisododecaneisodecyl isononanoatealcohol denat.lauryl peg-9 polydimethylsiloxyethyl dimethiconedimethicone silylatelaminaria saccharina extractsilk powder\serica\poudre de soiesodium hyaluronatetriethoxycaprylylsilanesorbitan sesquioleatetocopheryl acetatepropylene carbonatepolysilicone-11lecithinlaureth-7disteardimonium hectoritesilicadimethicone/peg-10/15 crosspolymersodium chloridexanthan gumtetrasodium edtaphenoxyethanol[+/- micatitanium dioxide (ci 77891)iron oxides (ci 77491)iron oxides (ci 77492)iron oxides (ci 77499)] [iln42344]

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

C

CLINIQUE

superbalanced
silk makeup
broad spectrum
SPF 15

1 FL.OZ.LIQ./30 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15 
octinoxate, octisalate, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.077 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.085 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.021 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
dimethicone (UNII: 92RU3N3Y1O)
water (UNII: 059QF0KO0R)
peg-10 dimethicone (600 cst) (UNII: 8PR7V1SVM0)
butylene glycol (UNII: 3XUS85K0RA)
phenyl trimethicone (UNII: DR0K5NOJ4R)
isododecane (UNII: A8289P68Y2)
isodecyl isononanoate (UNII: 4X46Q4U00Z)
alcohol (UNII: 3K9958V90M)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
saccharina latissima (UNII: 68CMP2MB55)
hyaluronate sodium (UNII: YSE9PPT4TH)
triethoxycaprylylsilane (UNII: LDC331P08E)
sorbitan sesquioleate (UNII: 0W8RRI5W5A)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
propylene carbonate (UNII: 8D08K3S51E)
dimethicone/vinyl dimethicone crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
laureth-7 (UNII: Z95S6G8201)
disteardimonium hectorite (UNII: X687XDK09L)
silicon dioxide (UNII: ETJ7Z6XBU4)
sodium chloride (UNII: 451W47IQ8X)
xanthan gum (UNII: TTV12P4NEE)
edetate sodium (UNII: MP1J8420LU)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
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: 49527-052-01	1 in 1 CARTON	07/15/2016
1		30 mL in 1 BOTTLE; 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	07/15/2016

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-052) , REPACK(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-052) , REPACK(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-052) , REPACK(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-052)