AVOBENZONE and OCTISALATE

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd. | The Estee Lauder Inc
Effective date
2023-10-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:56:27

Label at a glance#

ProductCLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO 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%
Octisalate 5%

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•cetyl alcohol•butylene glycol•sorbitan stearate•dimethicone•tridecyl stearate•peg-100 stearate• saccharomyces/xylinum/black tea ferment•sodium hyaluro-nate•astrocaryum murumuru seed butter•tridecyl trimellitate• dipentaerythrityl hexacaprylate/hexacaprate•algae extract• plankton extract•laminaria saccharina extract•whey protein\lactis protein\protéine du petit-lait•sigesbeckia orientalis (st. paul's wort) extract•acetyl glucosamine•glycine soja (soybean) protein•centaurium erythraea (centaury) extract•styrene/acrylates copolymer•cetyl palmitate•acrylates/c10-30 alkyl acrylate crosspolymer•polyethylene•acetyl hexapeptide-8•biotin• aminopropyl ascorbyl phosphate•sorbitan palmitate•sorbitan olivate•ethylhexylglycerin•caffeine•tocopheryl acetate•sodium polyacrylate•trehalose•peg-8 laurate•ergothioneine•lecithin• calcium chloride•hydroxyethylcellulose•sodium benzoate• tocopherol•citric acid•sodium hydroxide•pentylene glycol•sodium citrate•disodium edta•potassium sorbate•phenoxyethanol•chlorphenesin• yellow 5 (ci 19140)•red 4 (ci 14700) [iln48788]

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

clinique smart
broad spectrum SPF 15
custom-repair moisturizer

COMBINATION OILY TO OILY

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
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-050-01CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY1 in 1 CARTONCREAM19
49527-050-01CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY50 mL in 1 JARCREAM509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-050CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY (AVOBENZONE AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]9Current NDC, Legacy NDC, 2 package rows20231006_9c9a0fa4-b440-4d7f-805e-d997e120024d.zip

Products#

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

DailyMed product names page 1 of 2 · 57 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-05049527-050-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 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
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC9c9a0fa4-b440-4d7f-805e-d997e120024d2023-10-05WarningsExact identifier
ndc (package): 49527-050-01
ndc (product): 49527-050
ndc11 (package): 49527005001
spl id: 06fbb01f-2c86-510c-e063-6394a90a6516
spl set id: 9c9a0fa4-b440-4d7f-805e-d997e120024d

Reported adverse events (FAERS/openFDA)#

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