FDA.reportPublic FDA data

Cellromax Sun Block

Manufacturer
Pharmacist&Health Co., Ltd. | SOLEO COSMETIC Co., Ltd.
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:47

Label at a glance#

ProductCellromax Sun Block
Active ingredientZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 6.24%, Zinc Oxide 4.455%, Ethylhexyl Salicylate3.0%

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Dipropylene Glycol, Cetyl Ethylhexanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, 1,2-Hexanediol, Niacinamide, Methyl Methacrylate Crosspolymer, Dimethicone, Hydrogenated C6-14 Olefin Polymers, PEG-10 Dimethicone, Ozokerite, Sodium Chloride, Disteardimonium Hectorite, Barium Sulfate, Magnesium Stearate, Aluminum Hydroxide, Sorbitan Sesquioleate, Stearic Acid, Citric Acid, Dimethicone/PEG-10/15 Crosspolymer, Polysilicone-11, Polyhydroxystearic Acid, Lavandula Angustifolia (Lavender) Oil, Boswellia Carterii Oil, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Lecithin, Hydrogen Dimethicone, Adenosine, Polyglyceryl-3 Polyricinoleate, Silica, Disodium EDTA, Magnesium Myristate, Propylene Glycol, Tripropylene Glycol, Sodium Citrate, Allantoin, Portulaca Oleracea Extract, Tocopherol, Alanine, Arginine, Histidine, Tyrosine, Leucine, Methionine

OTC - PURPOSE SECTION

Purpose: Sunscreen

DESCRIPTION SECTION

Directions: 1. Apply after basic skin care product. 2. Spread an appropriate amount over the entire face following the skin texture. 3. Reapply as required.

OTC - STOP USE SECTION

Do not use on damaged or broken Skin. Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

WARNINGS SECTION

For external use only.

DOSAGE & ADMINISTRATION SECTION

Apply appropriate amount on your skin.

INDICATIONS & USAGE SECTION

Apply with your skin before direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cellromax SunblockCellromax Sunblock

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
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
79895-104-022022-01-28C16284748780-1d6a99b39-9871-a426-e053-dadaa90af4c2b444d3cf-4d44-6d08-e053-2a95a90ac6a1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79895-104-01Cellromax Sun Block50 mL in 1 CONTAINERCREAM501
79895-104-02Cellromax Sun Block1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79895-104CELLROMAX SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE) CREAM [PHARMACIST&HEALTH CO., LTD.]1Legacy NDC, 2 package rows20201117_b444d3cf-4d44-6d08-e053-2a95a90ac6a1.zip

Products#

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

DailyMed product names page 1 of 2 · 55 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79895-10479895-104-01, 79895-104-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
FRANKINCENSE OIL67ZYA5T02KIACT
ISOSTEARIC ACIDX33R8U0062IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
ADENOSINEK72T3FS567IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIPROPYLENE GLYCOL3C8845E7C1IACT
SODIUM CITRATE1Q73Q2JULRIACT
ALLANTOIN344S277G0ZIACT
TOCOPHEROLR0ZB2556P8IACT
ARGININE94ZLA3W45FIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
NIACINAMIDE25X51I8RD4IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)P0TX083987IACT
CERESINQ1LS2UJO3AIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
BARIUM SULFATE25BB7EKE2EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
LAVENDER OILZBP1YXW0H8IACT
ETHYLHEXYL PALMITATE2865993309IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALANINEOF5P57N2ZXIACT
HISTIDINE4QD397987EIACT
LEUCINEGMW67QNF9CIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT

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
b444d3cf-4d45-6d08-e053-2a95a90ac6a1b444d3cf-4d44-6d08-e053-2a95a90ac6a12020-11-16WarningsExact identifier
spl id: b444d3cf-4d45-6d08-e053-2a95a90ac6a1
spl set id: b444d3cf-4d44-6d08-e053-2a95a90ac6a1

Reported adverse events (FAERS/openFDA)#

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