REPAIRWEAR LASER FOCUS ALL SMOOTH MAKEUP BROAD SPECTRUM SPF 15- octocrylene and titanium dioxide lotion

REPAIRWEAR LASER FOCUS ALL SMOOTH MAKEUP BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

REPAIRWEAR LASER FOCUS ALL SMOOTH MAKEUP BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Len-Ron Manufacturing Division of Aramis Inc., Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., PALC, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octocrylene 2.0%
Titanium Dioxide 2.9%

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 methyl trimethicone phenyl trimethicone dimethicone triethylhexanoin butylene glycol trimethylsiloxysilicate peg-10 dimethicone lauryl peg-9 polydimethylsiloxyethyl dimethicone glycerin alumina astrocaryum murumuru seed butter whey protein\lactis protein\protéine du petit-lait sigesbeckia orientalis (st. paul's wort) extract micrococcus lysate acetyl hexapeptide-8 sodium hyaluronate palmitoyl oligopeptide sodium myristoyl sarcosinate dimethicone/peg-10/15 crosspolymer sodium chloride tocopheryl acetate acetyl glucosamine glyceryl polymethacrylate methicone disteardimonium hectorite lecithin dimethicone crosspolymer-3 peg-8 laureth-7 dipropylene glycol disodium edta polyaminopropyl biguanide phenoxyethanol [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77491, ci 77492, ci 77499) bismuth oxychloride (ci 77163)] [iln37900]

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

CLINIQUE

repairwear
laser focus

all-smooth
makeup
broad spectrum
SPF 15

1 FL.OZ.LIQ./30 ml e

INGREDIENTS AND APPEARANCE

REPAIRWEAR LASER FOCUS ALL SMOOTH MAKEUP BROAD SPECTRUM SPF 15 
octocrylene and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0231 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0335 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methyl trimethicone (UNII: S73ZQI0GXM)
phenyl trimethicone (UNII: DR0K5NOJ4R)
dimethicone (UNII: 92RU3N3Y1O)
triethylhexanoin (UNII: 7K3W1BIU6K)
butylene glycol (UNII: 3XUS85K0RA)
peg-10 dimethicone (600 cst) (UNII: 8PR7V1SVM0)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
glycerin (UNII: PDC6A3C0OX)
aluminum oxide (UNII: LMI26O6933)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
whey (UNII: 8617Z5FMF6)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
hyaluronate sodium (UNII: YSE9PPT4TH)
palmitoyl tripeptide-1 (UNII: RV743D216M)
sodium myristoyl sarcosinate (UNII: J07237209D)
sodium chloride (UNII: 451W47IQ8X)
n-acetylglucosamine (UNII: V956696549)
methicone (20 cst) (UNII: 6777U11MKT)
disteardimonium hectorite (UNII: X687XDK09L)
dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) (UNII: UF7620L1W6)
polyethylene glycol 400 (UNII: B697894SGQ)
laureth-7 (UNII: Z95S6G8201)
dipropylene glycol (UNII: E107L85C40)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
bismuth oxychloride (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-066-01	1 in 1 CARTON	01/01/2011
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	01/01/2011

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-066) , REPACK(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-066) , REPACK(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-066) , REPACK(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-066)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-066)