83918-001_solful face sun lotion

Manufacturer
KARA BEAUTY INC | Rebom Co., Ltd.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:52

Label at a glance#

Productsolful face sunlotion
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Sunscreen

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%, Octocrylene 5%, Octisalate 4%, Avobenzone 3%

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

Water, Dipropylene Glycol, Silica, Diphenylsiloxy Phenyl Trimethicone, Isohexadecane, Butyloctyl Salicylate, Polysorbate 80, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Benzyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Centella Asiatica Extract, Butylene Glycol, Ethylhexylglycerin, Propanediol, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Sodium Hyaluronate Crosspolymer, Lonicera Caprifolium (Honeysuckle) Extract, 1,2-Hexanediol, Hydrolyzed Glycosaminoglycans, Yeast Extract, Limonia Acidissima Extract, Glycerin, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Madecassic Acid, Asiaticoside, Asiatic Acid, Caprylyl Glycol, Hyaluronic Acid, Ascorbyl Glucoside, Sodium Ascorbyl Phosphate, Magnesium Ascorbyl Phosphate, Tetrahexyldecyl Ascorbate, Sodium Riboflavin Phosphate, Fragrance, Citral, Benzyl Salicylate, Linalool, Limonene

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description
image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e6383094-adb3-4e58-af3e-6e58e32b9740Product name220210330
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83918-001-022025-01-30C16284748780-12cef2736-7263-d83d-e063-dadaa90ab31f83918-001_solful face sun lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83918-001-01solful face sunlotion50 mL in 1 CONTAINERLOTION501
83918-001-02solful face sunlotion1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83918-001SOLFUL FACE SUNLOTION (HOMOSALATE, AVOBENZONE, OTISALATE, OCTOCRYLENE) LOTION [KARA BEAUTY INC]12 package rows20231229_1946b94b-43ae-4183-9eae-1112f0a2c951.zip

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83918-00183918-001-01, 83918-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 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
0d9b03a5-1bcc-f586-e063-6394a90a1bab1946b94b-43ae-4183-9eae-1112f0a2c9512023-12-28WarningsExact identifier
spl id: 0d9b03a5-1bcc-f586-e063-6394a90a1bab
spl set id: 1946b94b-43ae-4183-9eae-1112f0a2c951

Reported adverse events (FAERS/openFDA)#

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