REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY- octinoxate, octisalate, and titanium dioxide cream

REPAIRWEAR UPLIFTING FIRMING by

Drug Labeling and Warnings

REPAIRWEAR UPLIFTING FIRMING 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 7.5%
Octisalate 3.5%
Titanium dioxide 1.7%

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 neopentyl glycol diheptanoate simmondsia chinensis (jojoba) butter glycerin petrolatum octyldodecyl neopentanoate di-c12-15 alkyl fumarate dimethicone hydrogenated lecithin butylene glycol hydrogenated polyisobutene hexyldecyl stearate sigesbeckia orientalis (st. paul's wort) extract whey protein\lactis protein\protéine du petit-lait salvia sclarea (clary) extract chlorella vulgaris extract commiphora mukul resin extract litchi chinensis seed extract laminaria digitata extract cladosiphon okamuranus extract plankton extract astrocaryum murumuru seed butter acetyl hexapeptide-8 lecithin polyethylene pentylene glycol potato starch modified ergothioneine glyceryl stearate caffeine sorbitol behenyl alcohol sodium hyaluronate methicone tocopheryl acetate peg-100 stearate pentaerythrityl tetraethylhexanoate caprylyl glycol c12-16 alcohols cholesterol caprylic/capric triglyceride polysilicone-11 dextrin palmitic acid tetrahexyldecyl ascorbate hexylene glycol citric acid xanthan gum alumina ammonium acryloyldimethyltaurate/vp copolymer sodium hydroxide disodium edta potassium sorbate phenoxyethanol red 4 (ci 14700) yellow 5 (ci 19140) titanium dioxide (ci 77891) mica [iln39272]

Other information

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

SPL UNCLASSIFIED SECTION

DIST. N.Y., N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

C
CLINIQUE

repairwear uplifting

firming cream
broad spectrum SPF 15

DRY COMBINATION TO COMBINATION OILY

POIDS NET WT. 1.7. OZ./50 ml e

INGREDIENTS AND APPEARANCE

REPAIRWEAR UPLIFTING FIRMING   BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.078 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0364 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0176 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
jojoba butter (UNII: XIA46H803R)
glycerin (UNII: PDC6A3C0OX)
petrolatum (UNII: 4T6H12BN9U)
octyldodecyl neopentanoate (UNII: X8725R883T)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
hexyldecyl stearate (UNII: OJX2P28Y14)
clary sage (UNII: U3HSK5JC0Q)
chlorella vulgaris (UNII: RYQ4R60M02)
guggul (UNII: 34969JX79R)
litchi chinensis seed (UNII: 9294024N9Q)
laminaria digitata (UNII: 15E7C67EE8)
cladosiphon okamuranus (UNII: 2IJE0CH09J)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
high density polyethylene (UNII: UG00KM4WR7)
pentylene glycol (UNII: 50C1307PZG)
ergothioneine (UNII: BDZ3DQM98W)
glyceryl monostearate (UNII: 230OU9XXE4)
caffeine (UNII: 3G6A5W338E)
sorbitol (UNII: 506T60A25R)
docosanol (UNII: 9G1OE216XY)
hyaluronate sodium (UNII: YSE9PPT4TH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
peg-100 stearate (UNII: YD01N1999R)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
caprylyl glycol (UNII: 00YIU5438U)
c12-16 alcohols (UNII: S4827SZE3L)
cholesterol (UNII: 97C5T2UQ7J)
medium-chain triglycerides (UNII: C9H2L21V7U)
icodextrin (UNII: 2NX48Z0A9G)
palmitic acid (UNII: 2V16EO95H1)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
hexylene glycol (UNII: KEH0A3F75J)
citric acid monohydrate (UNII: 2968PHW8QP)
xanthan gum (UNII: TTV12P4NEE)
aluminum oxide (UNII: LMI26O6933)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
sodium hydroxide (UNII: 55X04QC32I)
edetate disodium (UNII: 7FLD91C86K)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)
FD&C red no. 4 (UNII: X3W0AM1JLX)
FD&C yellow no. 5 (UNII: I753WB2F1M)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-022-01	1 in 1 CARTON	10/01/2012
1		50 mL in 1 JAR; 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	10/01/2012

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-022) , REPACK(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-022) , REPACK(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-022) , REPACK(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-022)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-022)