SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30- avobenzone,homosalate,octinoxate,octisalate cream

SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Estee Lauder Cosmetics Ltd, Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

AVOBENZONE 3.0%
HOMOSALATE 7.0%
OCTINOXATE 3.5%
OCTISALATE 4.5%

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.

Direction

• 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, glycerin, butylene glycol, coco-caprylate/caprate, polyester-8, ethylhexyl methoxycrylene, butyloctyl salicylate, acrylates copolymer, dextrin palmitate, peg-100 stearate, silica, polyglyceryl-2 stearate, whey protein\lactis protein\protéine du petit-lait, algae extract, saccharomyces ferment, caprylyl glycol, sigesbeckia orientalis (st. paul's wort) extract, caffeine, lauroyl lysine, sodium hyaluronate, biosaccharide gum-1, 7-dehydrocholesterol, plankton extract, acetyl hexapeptide-8, palmitoyl tripeptide-1, palmitoyl hexapeptide-12, palmitoyl tetrapeptide-7, peg-8, tocopheryl acetate, pentylene glycol, hexylene glycol, sodium polyacryloyldimethyl taurate, stearyl alcohol, dehydroxanthan gum, dipropylene glycol, carbomer, potassium hydroxide, glyceryl polymethacrylate, acrylates/beheneth-25 methacrylate copolymer, lecithin, polysorbate 20, sorbitan sesquiisostearate, ppg-8-ceteth-20, glyceryl stearate, sorbeth-30 tetraisostearate, acrylates/c10-30 alkyl acrylate crosspolymer, bht, sodium citrate, disodium edta, phenoxyethanol, sodium benzoate, potassium sorbate <iln51459>

Other Information

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

Principal Display Panel

CLINIQUE

smart clinical repair

broad spectrum SPF 30

wrinkle correcting cream

CL1870 PEPTIDE COMPLEX

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 
avobenzone,homosalate,octinoxate,octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-100 STEARATE (UNII: YD01N1999R)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
WHEY (UNII: 8617Z5FMF6)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SIGESBECKIA ORIENTALIS WHOLE (UNII: ZM9Q0FEI4Z)
CAFFEINE (UNII: 3G6A5W338E)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
PPG-8-CETETH-20 (UNII: MAL0SND89Q)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAUROYL LYSINE (UNII: 113171Q70B)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-083-01	1 in 1 CARTON	05/12/2023
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49527-083-02	1 in 1 CARTON	05/12/2023
2		75 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 49527-083-03	1 in 1 CARTON	05/12/2023
3		15 mL in 1 JAR; Type 0: Not a Combination Product
4	NDC: 49527-083-04	1 in 1 CARTON	05/12/2023
4		5 mL in 1 JAR; Type 0: Not a Combination Product
5	NDC: 49527-083-05	1 in 1 CARTON	05/12/2023
5		30 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	05/12/2023

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd		202952982	manufacture(49527-083)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	manufacture(49527-083) , pack(49527-083) , label(49527-083)