REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION- octinoxate, octisalate, and titanium dioxide cream

REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION by

Drug Labeling and Warnings

REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION 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 pentaerythrityl tetraethylhexanoate hexyldecyl stearate polyethylene pentylene glycol potato starch modified citrus reticulata (tangerine) peel extract saccharomyces lysate extract polygonum cuspidatum root extract algae extract coffea robusta seed extract astrocaryum murumuru seed butter padina pavonica thallus extract betula alba (birch) bark extract creatine adenosine phosphate laurdimonium hydroxypropyl hydrolyzed soy protein linoleic acid hydrolyzed rice extract hydroxyproline triticum vulgare (wheat) germ extract hordeum vulgare (barley) extract\extrait d'orge sigesbeckia orientalis (st. paul's wort) extract coleus barbatus extract acetyl hexapeptide-8 sodium dna caffeine cholesterol ethylhexyl stearate sorbitol ethylhexyl palmitate decarboxy carnosine hcl phytosphingosine propylene glycol dicaprate tocopheryl acetate peg-100 stearate disodium nadh caprylyl glycol acrylates copolymer c12-16 alcohols polysilicone-11 squalane palmitic acid trehalose glyceryl stearate sodium rna dipalmitoyl hydroxyproline proline citric acid potassium sorbate aminopropyl ascorbyl phosphate behenyl alcohol methicone ammonium acryloyldimethyltaurate/vp copolymer hexylene glycol xanthan gum sodium hydroxide sodium hyaluronate aluminum hydroxide potassium sulfate glycine lecithin carbomer disodium edta phenoxyethanol [iln41738]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

de-aging

C
CLINIQUE

repairwear laser focus

line smoothing cream
broad spectrum SPF 15

VERY DRY TO DRY COMBINATION

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION 
octinoxate, octisalate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.076125 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.03745 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.015225 g  in 100 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)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
HEXYLDECYL STEARATE (UNII: OJX2P28Y14)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TANGERINE PEEL (UNII: JU3D414057)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
ROBUSTA COFFEE BEAN (UNII: V5032728L7)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
PADINA PAVONICA (UNII: 177U06NHZI)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
CREATINE (UNII: MU72812GK0)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
HYDROXYPROLINE (UNII: RMB44WO89X)
WHEAT GERM (UNII: YR3G369F5A)
BARLEY (UNII: 5PWM7YLI7R)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
CAFFEINE (UNII: 3G6A5W338E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
SORBITOL (UNII: 506T60A25R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-100 STEARATE (UNII: YD01N1999R)
DISODIUM NICOTINAMIDE ADENINE DINUCLEOTIDE (UNII: 8295030YNC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
PALMITIC ACID (UNII: 2V16EO95H1)
TREHALOSE (UNII: B8WCK70T7I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
PROLINE (UNII: 9DLQ4CIU6V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
DOCOSANOL (UNII: 9G1OE216XY)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
GLYCINE (UNII: TE7660XO1C)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-049-01	1 in 1 CARTON	10/01/2015
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	10/01/2015

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-049) , REPACK(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-049) , REPACK(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-049) , REPACK(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-049)