CELGEN MILD SUN

Manufacturer
BBHC CO., LTD | STC Nara Co., Ltd
Effective date
2020-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:42

Label at a glance#

ProductCELGEN MILD SUN
Active ingredientTITANIUM DIOXIDE, ETHYLHEXYL TRIAZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, BEMOTRIZINOL
Label structure9 sections

Dosage and administration

• Apply a proper amount evenly for the last step of skin care. • Apply liberally 15 minutes before sun exposure. • Reapply at least every two hours. • Use a water resistant sunscreen if swim- ming 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 an...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate (6.50%)

Ethylhexyl Salicylate (4.50%)

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (4.00%)

Titanium Dioxide (2.125%)

Ethylhexyl Triazone (1.50%)

Butyl Methoxydibenzoylmethane (0.90%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

DOSAGE & ADMINISTRATION SECTION

Helps to 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

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 use and ask a doctor

OTC - ASK DOCTOR SECTION

if irritation occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

• Apply a proper amount evenly for the last step of skin care.

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every two hours.

• Use a water resistant sunscreen if swim- ming 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 : 1) Limited time in the sun, especially from 10a.m-2p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses 3) Ask a doctor to use for children under 6 months.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Cyclopentasiloxane, Cetyl Ethylhexanoate, Silica, Butylene Glycol, Polymethyl Methacrylate, Dimethicone, Portulaca Oleracea Extract, Caprylhydroxamic Acid, Propanediol, Arginine, Glyceryl Stearate, PEG-100 Stearate, 1,2-Hexanediol, Caprylyl Glycol, Polysorbate 60, Carbomer, Fragrance, Red Ginseng Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Sodium Chloride, Glucose

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50g NDC: 76731-204-01 Label50g NDC: 76731-204-01 Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
76731-204-012022-01-28C16284748780-1d6a99b39-fb58-a426-e053-dadaa90af4c276731-204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76731-204-01CELGEN MILD SUN50 g in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76731-204CELGEN MILD SUN (OCTINOXATE, OCTISALATE, BEMOTRIZINOL, TITANIUM DIOXIDE, ETHYLHEXYL TRIAZONE, AVOBENZONE) CREAM [BBHC CO., LTD]1Legacy NDC, 1 package rows20200903_ae604fe2-8251-555e-e053-2995a90ac018.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76731-20476731-204-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
ae604fe2-8252-555e-e053-2995a90ac018ae604fe2-8251-555e-e053-2995a90ac0182020-09-02WarningsExact identifier
spl id: ae604fe2-8252-555e-e053-2995a90ac018
spl set id: ae604fe2-8251-555e-e053-2995a90ac018

Reported adverse events (FAERS/openFDA)#

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