FDA.reportPublic FDA data

FULLY RICE CERAMIDE MOISTURE SUNSCREEN

Manufacturer
Adapt Inc. | Kolmar Korea Co., Ltd
Effective date
2026-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:47:19

Label at a glance#

ProductFULLY RICE CERAMIDE MOISTURE SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%

Homosalate 13.6%

Octisalate 4.5%

Octocrylene 9.0%

OTC - PURPOSE SECTION

Sunscreen

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.

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

DOSAGE & ADMINISTRATION SECTION

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 of 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 10 am to 2 pm. - Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT SECTION

WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, C20-22 ALKYL PHOSPHATE, SILICA, POLYMETHYLSILSESQUIOXANE, C20-22 ALCOHOLS, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, PANTHENOL, METHYL TRIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL STEARATE, VP/EICOSENE COPOLYMER, TROMETHAMINE, POLYACRYLATE CROSSPOLYMER-6, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BUTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, METHYLPROPANEDIOL, POLYETHER-1, CERAMIDE NP, ORYZA SATIVA (RICE) BRAN OIL, TOCOPHEROL, ORYZA SATIVA (RICE) BRAN WATER, BIOSACCHARIDE GUM-1

OTHER SAFETY INFORMATION

Protect the product in the container from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87343-001-01FULLY RICE CERAMIDE MOISTURE SUNSCREEN50 mL in 1 TUBECREAM501
87343-001-02FULLY RICE CERAMIDE MOISTURE SUNSCREEN1 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87343-00187343-001-01, 87343-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PROPANEDIOL5965N8W85TIACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
C20-22 ALCOHOLSO4M0347C6AIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PENTYLENE GLYCOL50C1307PZGIACT
PANTHENOLWV9CM0O67ZIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
TROMETHAMINE023C2WHX2VIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
POLYETHER-1 (2800 MPA.S)6QR7NJP3G8IACT
CERAMIDE NP4370DF050BIACT
RICE BRAN OILLZO6K1506AIACT
TOCOPHEROLR0ZB2556P8IACT
RICE BRAN, DEFATTEDH6597RO5A2IACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
FULLY RICE CERAMIDE MOISTURE SUNSCREENZINC OXIDEAdapt Inc.d8bfe222-3184-4c98-9876-ef5ac81772b62026-02-24WarningsExact identifier
ndc (package): 87343-001-02
ndc (package): 87343-001-01
ndc (product): 87343-001
ndc11 (package): 87343000102
ndc11 (package): 87343000101
spl id: 4b8ed00c-c415-8a9e-e063-6294a90adb50
spl set id: d8bfe222-3184-4c98-9876-ef5ac81772b6

Reported adverse events (FAERS/openFDA)#

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