CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40- octinoxate, octisalate, and titanium dioxide cream

CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40 by

Drug Labeling and Warnings

CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., J.O. COSMETICS, Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 2.0%
Titanium Dioxide 1.6%

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

water\aqua\eau methyl trimethicone alcohol ethylhexyl palmitate peg-9 polydimethylsiloxyethyl dimethicone propanediol glycerin glyceryl caprylate peg-3 dimethicone dimethicone tocopheryl acetate lecithin triethoxycaprylylsilane stearyl glycyrrhetinate sorbitan sesquiisostearate sodium hyaluronate pyridoxine hcl palmitoyl tetrapeptide-7 dipeptide-2 stearic acid hesperidin methyl chalcone sodium chloride aluminum hydroxide steareth-20 silica sodium citrate phenoxyethanol [+/- mica iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499) titanium dioxide (ci 77891)] [iln43830]

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

CLINIQUEFIT

BE MATTE
ON THE MAT.

WORKOUT
MAKEUP
BROAD
SPECTRUM
SPF 40

C

INGREDIENTS AND APPEARANCE

CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40 
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0218 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01744 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methyl trimethicone (UNII: S73ZQI0GXM)
alcohol (UNII: 3K9958V90M)
ethylhexyl palmitate (UNII: 2865993309)
peg-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
propanediol (UNII: 5965N8W85T)
glycerin (UNII: PDC6A3C0OX)
glyceryl monocaprylate (UNII: TM2TZD4G4A)
dimethicone (UNII: 92RU3N3Y1O)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
palmitoyl tetrapeptide-7 (UNII: Q41S464P1R)
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)
stearic acid (UNII: 4ELV7Z65AP)
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)
sodium chloride (UNII: 451W47IQ8X)
aluminum hydroxide (UNII: 5QB0T2IUN0)
steareth-20 (UNII: L0Q8IK9E08)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
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: 49527-055-01	1 in 1 CARTON	02/15/2017
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	02/15/2017

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-055) , REPACK(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-055) , REPACK(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-055) , REPACK(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-055)

Establishment
Name	Address	ID/FEI	Business Operations
J.O. COSMETICS		691704652	MANUFACTURE(49527-055)