FDA.reportPublic FDA data

Sea Clearly Hydrating Facial SPF 35 Kinetin

Manufacturer
Allure Labs
Effective date
2023-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:03:19

Label at a glance#

ProductSea Clearly Hydrating Facial SPF 35 Kinetin
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient,

Octocrylene – 10 %

Octisalate – 5%

Homosalate – 5%

Avobenzone – 2.5 %

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses. Helps prevent sunburn.

If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

Warnings

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 eye.Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask doctor if skin 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.

DOSAGE & ADMINISTRATION SECTION

Directions.

Apply generously and evenly 15 minutes before sun exposure.

Reapply: after 40 minutes of swimming or sweating.

Immediately after towel drying. At least every 2 hours.

Sun Protection Measures: Spending time the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of 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.

OTHER SAFETY INFORMATION

Other information.

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredient:

Isododecane, Polymethylsilsesquioxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Dimethicone Crosspolymer, Dimethicone,Camellia Oleifera (Seed) Oil,Prunus Armeniaca (Apricot) Kernel Oil, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Kinetin, Squalane,Tocopherol, Tocopheryl Acetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sea Clearly Hydrating Facial SPF 35Sea Clearly Hydrating Facial SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4237-1Sea Clearly Hydrating Facial SPF 35 Kinetin50 g in 1 BOTTLE, PUMPCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4237SEA CLEARLY HYDRATING FACIAL SPF 35 KINETIN (OCTOCRYLENE, OCTISALATE,HOMOSALAT, AVOBENZONE) CREAM [ALLURE LABS]1Current NDC, 1 package rows20231207_0bc829ff-34a0-03e9-e063-6294a90a10ae.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-423762742-4237-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
OCTISALATE4X49Y0596WACTIB
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEX2PZH4Y6HTIACT
KINETINP39Y9652YJIACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
TOCOPHEROLR0ZB2556P8IACT
CAMELLIA OILT1PE06G0VEIACT
APRICOT KERNEL OIL54JB35T06AIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE92RU3N3Y1OIACT
SAFFLOWER OIL65UEH262ISIACT
SQUALANEGW89575KF9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
Sea Clearly Hydrating Facial SPF 35 KinetinOCTOCRYLENE, OCTISALATE,HOMOSALAT, AVOBENZONEAllure Labs0bc829ff-34a0-03e9-e063-6294a90a10ae2023-12-05WarningsExact identifier
ndc (package): 62742-4237-1
ndc (product): 62742-4237
ndc11 (package): 62742423701
spl id: 0bc829ff-34a1-03e9-e063-6294a90a10ae
spl set id: 0bc829ff-34a0-03e9-e063-6294a90a10ae

Reported adverse events (FAERS/openFDA)#

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