AVOBENZONE, HOMOSALATE, and OCTISALATE

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | The Estee Lauder Inc
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:57:02

Label at a glance#

ProductSUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION
Active ingredientAVOBENZONE, HOMOSALATE, 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%
Homosalate 5.0%
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 • dimethicone • polyester-8 • cetearyl alcohol • glyceryl stearate • peg-100 stearate • shea butter ethyl esters • butylene glycol • petrolatum • styrene/acrylates copolymer • glycerin • niacinamide • trehalose • vp/eicosene copolymer • daucus carota sative (carrot) root extract • brassica oleracea gemmifera (brussels sprouts) extract • vaccinium macrocarpon (cranberry) fruit extract • resveratrol • brassica oleracea italica (broccoli) extract • acetyl carnitine hcl • vaccinium angustifolium (blueberry) fruit extract • salicylic acid • brassica oleracea acephala (kale) leaf extract • creatine • spinacia oleracea (spinach) leaf extract • cucumis sativus (cucumber) fruit extract • lactobacillus ferment • adenosine phosphate • hordeum vulgare (barley) extract\extrait d'orge • sigesbeckia orientalis (st. paul's wort) extract • albizia julibrissin bark extract • arabidopsis thaliana extract • plankton extract • isohexadecane • oryza sativa (rice) bran extract • potassium cetyl phosphate • tocopheryl acetate • caffeine • ethylhexylglycerin • algae extract • micrococcus lysate • ergothioneine • sodium hyaluronate • 7-dehydrocholesterol • caprylyl glycol • biosaccharide gum-4 • hydrogenated palm glycerides • acrylates/c10-30 alkyl acrylate crosspolymer • propylene glycol dicaprate • peg-8 laurate • helianthus annuus (sunflower) seedcake • polyethylene • yeast extract\faex\extrait de levure • tromethamine • dimethiconol • sodium rna • polysorbate 80 • lecithin • sea whip extract • xanthan gum • acrylamide/sodium acryloyldimethyltaurate copolymer • tetrahexyldecyl ascorbate • propylene glycol caprylate • phytic acid • disodium edta • bht • phenoxyethanol • mica • titanium dioxide (ci 77891) [iln44658]

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

de-aging

CLINIQUE

superdefense
broad spectrum SPF 25

fatigue + 1 st signs of age
multi-correcting cream

VERY DRY TO DRY COMBINATION

NET WT. 1.7 OZ./50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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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
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96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-077-01SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION1 in 1 CARTONCREAM17
49527-077-01SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION50 mL in 1 JARCREAM507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-077SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION (AVOBENZONE, HOMOSALATE, AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]7Current NDC, Legacy NDC, 2 package rows20231020_b0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be0.zip

Products#

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

DailyMed product names page 1 of 2 · 63 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-07749527-077-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 61 matching rows.

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
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATIONAVOBENZONE, HOMOSALATE, AND OCTISALATECLINIQUE LABORATORIES LLCb0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be02023-10-19WarningsExact identifier
ndc (package): 49527-077-01
ndc (product): 49527-077
ndc11 (package): 49527007701
spl id: 0817d141-8c8f-3e19-e063-6394a90a8311
spl set id: b0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be0

Reported adverse events (FAERS/openFDA)#

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