REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O- octinoxate, titanium dioxide cream

REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O by

Drug Labeling and Warnings

REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., The Estee Lauder Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%
Titanium Dioxide 1.5%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

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,cetyl ethylhexanoate,butylene glycol,octyldodecyl neopentanoate,peg-100 stearate,glyceryl stearate,glycerin,hydrogenated lecithin,polyethylene,pentylene glycol,silica,citrus reticulata (tangerine) peel extract,saccharomyces lysate extract,polygonum cuspidatum root extract,algae extract,triticum vulgare (wheat) bran 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,olea europaea (olive) fruit extract,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,disodium nadh,caprylyl glycol,acrylates copolymer,trehalose,sodium rna,cetyl alcohol,dipalmitoyl hydroxyproline,proline,aminopropyl ascorbyl phosphate,behenyl alcohol,methicone,hexylene glycol,xanthan gum,sodium hyaluronate,potassium hydroxide,potassium sulfate,glycine,potassium sorbate,aluminum hydroxide,lecithin,carbomer,disodium edta,phenoxyethanol <iln41741>

Other information

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

PRINCIPAL DISPLAY PANEL

CLINIQUE

repairwear laser focus

line smoothing cream

braod spectrum SPF 15

COMBINATION OILY TO OILY

POIDS NET WT. 1.7 OZ/50 ml e

INGREDIENTS AND APPEARANCE

REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DISODIUM NICOTINAMIDE ADENINE DINUCLEOTIDE (UNII: 8295030YNC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
METHICONE (20 CST) (UNII: 6777U11MKT)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CAFFEINE (UNII: 3G6A5W338E)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DOCOSANOL (UNII: 9G1OE216XY)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROXYPROLINE (UNII: RMB44WO89X)
GLYCINE (UNII: TE7660XO1C)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TANGERINE PEEL (UNII: JU3D414057)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PADINA PAVONICA (UNII: 177U06NHZI)
CREATINE (UNII: MU72812GK0)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
COLEUS BARBATUS ROOT (UNII: V5741391RG)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
WHEAT BRAN (UNII: 6L966A1IMR)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
BLACK OLIVE (UNII: 2M6QWV94OC)
SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
PROLINE (UNII: 9DLQ4CIU6V)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ROBUSTA COFFEE BEAN (UNII: V5032728L7)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
TREHALOSE (UNII: B8WCK70T7I)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SOYBEAN (UNII: L7HT8F1ZOD)
SORBITOL (UNII: 506T60A25R)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-118-01	1 in 1 CARTON	02/09/2024
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 Drug	M020	02/09/2024

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	pack(49527-118) , manufacture(49527-118) , label(49527-118)