FDA.reportPublic FDA data

SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd | Estee Lauder Cosmetics Ltd.
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:17

Label at a glance#

ProductSMART CLINICAL REPAIR BROAD SPECTRUM SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure8 sections

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For External use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Direction

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelCLINIQUE

smart clinical repair

broad spectrum SPF 30

wrinkle correcting cream

CL1870 PEPTIDE COMPLEX

POIDS NET WT. 1.7 OZ./50 ml e

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-083-01SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-01SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3050 mL in 1 JARCREAM502
49527-083-02SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3075 mL in 1 JARCREAM752
49527-083-02SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-03SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-03SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3015 mL in 1 JARCREAM152
49527-083-04SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-04SMART CLINICAL REPAIR BROAD SPECTRUM SPF 305 mL in 1 JARCREAM52
49527-083-05SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3030 mL in 1 JARCREAM302
49527-083-05SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-083SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 (AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]2Current NDC, 10 package rows20231116_fb841fd7-0c78-01a1-e053-6394a90a4382.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 52 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-08349527-083-01, 49527-083-02, 49527-083-03, 49527-083-04, 49527-083-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-100 STEARATEYD01N1999RIACT
POLYGLYCERYL-2 STEARATE253MC0P0YVIACT
WHEY8617Z5FMF6IACT
PORPHYRIDIUM PURPUREUMK2P8K2558NIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYALURONATE SODIUMYSE9PPT4THIACT
7-DEHYDROCHOLESTEROLBK1IU07GKFIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
GLYCERINPDC6A3C0OXIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SODIUM POLYACRYLOYLDIMETHYL TAURATENG5NG5733TIACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
OCTINOXATE4Y5P7MUD51ACTIB
SIGESBECKIA ORIENTALIS WHOLEZM9Q0FEI4ZIACT
CAFFEINE3G6A5W338EIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
STEARYL ALCOHOL2KR89I4H1YIACT
DIPROPYLENE GLYCOLE107L85C40IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYSORBATE 207T1F30V5YHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PENTYLENE GLYCOL50C1307PZGIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCfb841fd7-0c78-01a1-e053-6394a90a43822023-11-15WarningsExact identifier
ndc (package): 49527-083-03
ndc (package): 49527-083-01
ndc (package): 49527-083-05
ndc (package): 49527-083-04
ndc (package): 49527-083-02
ndc (product): 49527-083
ndc11 (package): 49527008305
ndc11 (package): 49527008304
ndc11 (package): 49527008301
ndc11 (package): 49527008302
ndc11 (package): 49527008303
spl id: 0a35474f-c644-433e-e063-6294a90a3a75
spl set id: fb841fd7-0c78-01a1-e053-6394a90a4382

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.