FDA.reportPublic FDA data

AVOBENZONE and OCTISALATE

Manufacturer
CLINIQUE LABORATORIES LLC | ESTEE LAUDER COMPANY, THE | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTHTEC INC | PADC 1 | WHITMAN LABORATORIES, LTD.
Effective date
2019-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:01:34

Label at a glance#

ProductSUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (COMBINATION OILY - OILY)
Active ingredientAVOBENZONE, OCTISALATE
Label structure9 sections

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%
Octisalate 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 • butyloctyl salicylate • glycerin • polyester-8 • polysorbate 60 • dimethicone • butylene glycol • cetyl alcohol • sorbitan stearate • tridecyl stearate • peg-100 stearate • trehalose • sigesbeckia orientalis (st. paul's wort) extract • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • arabidopsis thaliana extract • laminaria saccharina extract • plankton extract • algae extract • sea whip extract • lactobacillus ferment • micrococcus lysate • ergothioneine • caffeine • lecithin • sodium hyaluronate • pentylene glycol • tridecyl trimellitate • dipentaerythrityl hexacaprylate/hexacaprate • tocopheryl acetate • ethylhexylglycerin • squalane • cetyl palmitate • acrylates/c10-30 alkyl acrylate crosspolymer • sorbitan palmitate • sorbitan olivate • polyethylene • sodium benzoate • ethylene/va copolymer • tetrahexyldecyl ascorbate • dimethiconol • sodium polyacrylate • sodium hydroxide • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • phenoxyethanol • chlorphenesin [iln39715]

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

age prevention

C

CLINIQUE

superdefense

daily defense moisturizer
broad spectrum SPF 20

COMBINATION OILY TO OILY

POIDS NET WT. 1.7 OZ./50 ml e

Principal Display Panel - 50 mL Jar Carton
Principal Display Panel - 50 mL Jar Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTISALATEACTIVE MOIETY4X49Y0596W1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
butylene glycolINACTIVE INGREDIENT3XUS85K0RA1
butyloctyl salicylateINACTIVE INGREDIENT2EH13UN8D31
caffeineINACTIVE INGREDIENT3G6A5W338E1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08X1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
dipentaerythrityl hexacaprylate/hexacaprateINACTIVE INGREDIENT554N82UWVW1
edetate disodiumINACTIVE INGREDIENT7FLD91C86K1
ergothioneineINACTIVE INGREDIENTBDZ3DQM98W1
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR71
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4TH1
peg-100 stearateINACTIVE INGREDIENTYD01N1999R1
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)INACTIVE INGREDIENT255PIF62MS1
pentylene glycolINACTIVE INGREDIENT50C1307PZG1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
pseudopterogorgia elisabethaeINACTIVE INGREDIENTUDY3H1OUX51
saccharina latissimaINACTIVE INGREDIENT68CMP2MB551
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
sorbitan monopalmitateINACTIVE INGREDIENT77K6Z421KU1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X1
sorbitan olivateINACTIVE INGREDIENTMDL271E3GR1
squalaneINACTIVE INGREDIENTGW89575KF91
tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZ1
trehaloseINACTIVE INGREDIENTB8WCK70T7I1
tridecyl stearateINACTIVE INGREDIENTA8OE252M6L1
tridecyl trimellitateINACTIVE INGREDIENTFY36J270ES1
waterINACTIVE INGREDIENT059QF0KO0R1
wheat germINACTIVE INGREDIENTYR3G369F5A1

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-03749527-037-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
water059QF0KO0RIACT
butyloctyl salicylate2EH13UN8D3IACT
glycerinPDC6A3C0OXIACT
polysorbate 60CAL22UVI4MIACT
dimethicone92RU3N3Y1OIACT
butylene glycol3XUS85K0RAIACT
cetyl alcohol936JST6JCNIACT
sorbitan monostearateNVZ4I0H58XIACT
tridecyl stearateA8OE252M6LIACT
peg-100 stearateYD01N1999RIACT
trehaloseB8WCK70T7IIACT
wheat germYR3G369F5AIACT
saccharina latissima68CMP2MB55IACT
pseudopterogorgia elisabethaeUDY3H1OUX5IACT
ergothioneineBDZ3DQM98WIACT
caffeine3G6A5W338EIACT
hyaluronate sodiumYSE9PPT4THIACT
pentylene glycol50C1307PZGIACT
tridecyl trimellitateFY36J270ESIACT
dipentaerythrityl hexacaprylate/hexacaprate554N82UWVWIACT
.alpha.-tocopherol acetate9E8X80D2L0IACT
ethylhexylglycerin147D247K3PIACT
squalaneGW89575KF9IACT
cetyl palmitate5ZA2S6B08XIACT
sorbitan monopalmitate77K6Z421KUIACT
sorbitan olivateMDL271E3GRIACT
high density polyethyleneUG00KM4WR7IACT
sodium benzoateOJ245FE5EUIACT
tetrahexyldecyl ascorbate9LBV3F07AZIACT
sodium hydroxide55X04QC32IIACT
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)255PIF62MSIACT
edetate disodium7FLD91C86KIACT
phenoxyethanolHIE492ZZ3TIACT
chlorphenesinI670DAL4SZIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 458 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
cetyl palmitateCETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SOLUTION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / PERIODONTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
caffeineCAFFEINE3G6A5W338EGRANULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE, EXTENDED RELEASE / ORAL4.53 mgExact identifier — unii candidate
18 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XSOLUTION / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RESPIRATORY (INHALATION)8 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5.4 mgExact identifier — unii candidate
174 equally ranked IID candidates
caffeineCAFFEINE3G6A5W338ESOLUTION / OPHTHALMIC2 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
peg-100 stearatePEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii candidate
3 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSPRAY / TOPICAL4.58 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates

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
72fdaf9b-1bb1-40d6-a0dd-9514689dc3a9c81bf13c-aee0-42ff-ada5-b3cf537f92852021-07-19WarningsExact identifier
spl set id: c81bf13c-aee0-42ff-ada5-b3cf537f9285

Reported adverse events (FAERS/openFDA)#

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