AVOBENZONE and OCTISALATE

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | The Estee Lauder Inc
Effective date
2023-10-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:56:47

Label at a glance#

ProductCLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25
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 Posion 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 • glycerin • neopentyl glycol diheptanoate • polyester-8 • dimethicone • sorbitan stearate • butyloctyl salicylate • polysorbate 60 • butylene glycol • sodium acrylates copolymer • niacinamide • sodium hyaluronate • acetyl carnitine hcl • creatine • brassica oleracea gemmifera (brussels sprouts) extract • vaccinium angustifolium (blueberry) fruit extract • brassica oleracea italica (broccoli) extract • daucus carota sativa (carrot) root extract • brassica oleracea acephala (kale) leaf extract • spinacia oleracea (spinach) leaf extract • albizia julibrissin bark extract • cucumis sativus (cucumber) fruit extract • vaccinium macrocarpon (cranberry) fruit extract • plankton extract • laminaria saccharina extract • caffeine • adenosine phosphate • sea whip extract • yeast extract\faex\extrait de levure • sodium rna • phytic acid • lactobacillus ferment • algae extract • hordeum vulgare (barley) extract\extrait d'orge • silica • resveratrol • cetyl alcohol • tocopheryl acetate • sigesbeckia orientalis (st. paul's wort) extract • pentylene glycol • trehalose • styrene/acrylates copolymer • lecithin • helianthus annuus (sunflower) seedcake • micrococcus lysate • arabidopsis thaliana extract • biosaccharide gum-4 • ergothioneine • oryza sativa (rice) bran extract • capryloyl glycine • salicylic acid • isohexadecane • peg-8 laurate • polysorbate 80 • ethylhexylglycerin • propylene glycol dicaprate • 7-dehydrocholesterol • peg-100 stearate • acrylamide/sodium acryloyldimethyltaurate copolymer • tetrahexyldecyl ascorbate • propylene glycol caprylate • polyethylene • disodium edta • bht • phenoxyethanol • chlorphenesin • mica • titanium dioxide (ci 77891) [iln44783]

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 48 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINIQUE
FOR MEN

super
energizer

anti-fatigue
hydrating concentrate
broad spectrum
SPF 25

UVA/B + IR + BLUE LIGHT DEFENSE

1.6 FL.OZ.LIQ./48 ml e

PRINCIPAL DISPLAY PANEL - 48 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 48 ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
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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
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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
49527-063-01CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 251 in 1 CARTONCREAM17
49527-063-01CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 2548 mL in 1 BOTTLECREAM487

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-063CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING CONCENTRATE BROAD SPECTRUM SPF 25 (AVOBENZONE AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]7Current NDC, Legacy NDC, 2 package rows20231014_f1109f0e-ebf5-450e-8a4e-b314a91b2483.zip

Products#

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

DailyMed product names page 1 of 2 · 62 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-06349527-063-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 60 matching rows.

Source Document#

Source XML · Source PDF

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
CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25AVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLCf1109f0e-ebf5-450e-8a4e-b314a91b24832023-10-13WarningsExact identifier
ndc (package): 49527-063-01
ndc (product): 49527-063
ndc11 (package): 49527006301
spl id: 0799f11b-4622-0a97-e063-6394a90a17ed
spl set id: f1109f0e-ebf5-450e-8a4e-b314a91b2483

Reported adverse events (FAERS/openFDA)#

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