FDA.reportPublic FDA data

Facet Daily Moisturizer SPF 35

Manufacturer
Cosco International, Inc.
Effective date
2022-09-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:37

Label at a glance#

ProductFacet Daily Moisturizer SPF 35
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, OCTINOXATE
Label structure10 sections

Indications and uses

Helps prevent sunburn.  If used as directed with other sun protection measures, (see directions), decreases the risk of skin cancer and early skin aging caused by the sun. Higher SPF gives more subburn protection

Dosage and administration

Use only as directed Apply liberally and spread evenly 15 minutes before sun exposure Reapply at least every 2 hours or immediately after towel drying Use a water-resistant sunscreen if swimming or sweating For children under 6 months of age:  Ask a doctor Sun Protection Measures  s pending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen w...

Storage and handling

Protect the product in this container from excessuve heat and direct sun Store at temperatures below 90°F May discolor some fabrics.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient....................Purpose

Avobenxone 3.00%..................Sunscreen

Octocrylene 9.50%..................Sunscreen

Octilsalate 5.00%....................Sunscreen

Octinoxate 7.50%....................Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.  If used as directed with other sun protection measures, (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Higher SPF gives more subburn protection

Warnings

WARNINGS SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - WHEN USING SECTION

When using this product 

  • keep out of eyes.  Rinse with water to remove.

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

Directions

INSTRUCTIONS FOR USE SECTION

  • Use only as directed
  • Apply liberally and spread evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours or immediately after towel drying
  • Use a water-resistant sunscreen if swimming or sweating
  • For children under 6 months of age:  Ask a doctor

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glyceryl Stearate SE, Alkyl (C12-15) Benzoate, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Stearate/PEG-100 Stearate, Cetostearyl Alcohol, Ceteareth 20, Isopropyl Myristate, Dimethicone, Phenoxyethanol, Butylene Glycol, Glycerin, Jojoba Oil, Caprylyl Glycol, Carbomer Interpolymer Type B (Allyl Pentaerythritol Crosslinked), Niacinamide (vitamin B3), Panthenol, Sodium Chloride, Sodium Hydroxide, Sodium Hyaluronate, Hyaluronic Acid

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessuve heat and direct sun
  • Store at temperatures below 90°F
  • May discolor some fabrics.

Questions or Comments?

OTC - QUESTIONS SECTION

Call (855) 658-8855

SPL UNCLASSIFIED SECTION

Distributed by

Thirty Madison

New York, NY, 1001

(855) 658-8855

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3ml label3ml label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2oz label2oz label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2oz carton2oz carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-0800-02025-01-30C16284748780-12cef2736-9fcd-d83d-e063-dadaa90ab31fFacet Daily Moisturizer + SPF 35
52261-0800-12025-01-30C16284748780-12cef2736-9fcd-d83d-e063-dadaa90ab31fFacet Daily Moisturizer + SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0800-0Facet Daily Moisturizer SPF 350.003 kg in 1 PACKETLOTION0.0032
52261-0800-1Facet Daily Moisturizer SPF 350.059 kg in 1 BOTTLE, PUMPLOTION0.0592
52261-0800-1Facet Daily Moisturizer SPF 351 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0800FACET DAILY MOISTURIZER SPF 35 (AVOBENZONE, OCTOCRYLENE, OCTISALATE, OCTINOXATE) LOTION [COSCO INTERNATIONAL, INC.]2Legacy NDC, 3 package rows20220910_0f6745bd-975a-4812-9305-aecb50451663.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-080052261-0800-1, 52261-0800-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
DIMETHICONE 3502Y53S6ATLUIACT
SODIUM HYDROXIDE55X04QC32IIACT
NIACINAMIDE25X51I8RD4IACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
PANTHENOLWV9CM0O67ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
HYALURONIC ACIDS270N0TRQYIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
JOJOBA OIL724GKU717MIACT

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
669e7de9-8e87-4e2b-a775-b50bee4032bc0f6745bd-975a-4812-9305-aecb504516632022-09-01WarningsExact identifier
spl id: 669e7de9-8e87-4e2b-a775-b50bee4032bc
spl set id: 0f6745bd-975a-4812-9305-aecb50451663

Reported adverse events (FAERS/openFDA)#

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