FDA.reportPublic FDA data

CareCella Day Cream

Manufacturer
General Bio Co., Ltd.
Effective date
2017-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:52

Label at a glance#

ProductCareCella Day Cream
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure11 sections

Indications and uses

• 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

Dosage and administration

• Apply liberally and evenly 15 minutes before sun exposure • Children under 6 months of age: Ask a doctor • Reapply at least every 2 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 value of 15 or higher and other ...

Storage and handling

• Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

​Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 7.5%

​Purpose

OTC - PURPOSE SECTION

Sunscreen

​Uses

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

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 if • 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.

​Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally and evenly 15 minutes before sun exposure

• Children under 6 months of age: Ask a doctor

• Reapply at least every 2 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 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.

​Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Niacinamide, Butylene Glycol, Dipropylene Glycol, Trisiloxane, Common Purslane (Portulaca Oleracea) Extract, 1,2-Hexanediol, Magnesium Aluminum Silicate, Arginine, Cetearyl Olivate, Sorbitan Olivate, Glyceryl Stearate, Cetearyl Alcohol, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Disodium EDTA, Scots Pine (Pinus sylvestris) Leaf Oil, Adenosine, Sodium Hyaluronate, Hydrolyzed Collagen Extract, Comfrey (Symphytum Officinale) Leaf Extract, Hydrogenated Lecithin, Diethoxyethyl Succinate, Phospholipids, Caprylic/Capric Triglyceride, Ceramide NP, Wild Mint (Mentha Arvensis) Leaf Oil, Polyglyceryl-10 Laurate, Caprylyl Glycol, Copper Tripeptide-1, Tripeptide-29, Nicotinoyl Tripeptide-1, Hexapeptide-9, Acetyl Hexapeptide-8

​Other information

STORAGE AND HANDLING SECTION

• Protect the product in this container from excessive heat and direct sun.

​Questions or comments?

OTC - QUESTIONS SECTION

Call +1-213-568-3732

Monday-Friday 9 a.m.-6 p.m. Pacific Time

You may also report serious side effects to this phone number

SPL UNCLASSIFIED SECTION

Protects your skin from the external sun light during the day, as well as moisturizes the skin.

SUNSCREEN CREAM
BROAD SPECTRUM SPF 50

Distributed by​ GCOOP USA CORP. 1032 S. Crenshaw Blvd. #C-2 2ND Floor Los Angeles, CA 90019 Visit at us.gcoop.com

GB GENERAL BIO

Made in Korea

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
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
69422-1302-12020-01-31C16284748780-19d75b9d0-42d0-f424-e053-dadaa90a57ceCareCella Day Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69422-1302-1CareCellaDay Cream1 in 1 BOXCREAM12
69422-1302-1CareCellaDay Cream50 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69422-1302CARECELLA DAY CREAM (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) CREAM [GENERAL BIO CO., LTD.]2Legacy NDC, 2 package rows20171230_a4eb4054-ba66-41d6-897c-3ab93cad53db.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69422-130269422-1302-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
NIACINAMIDE25X51I8RD4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIPROPYLENE GLYCOLE107L85C40IACT
TRISILOXANE9G1ZW13R0GIACT
PURSLANEM6S840WXG5IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ARGININE94ZLA3W45FIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLORPHENESINI670DAL4SZIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
ADENOSINEK72T3FS567IACT
HYALURONATE SODIUMYSE9PPT4THIACT
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)2WID9OCG7PIACT
COMFREY LEAFDG4F8T839XIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
DIETHOXYETHYL SUCCINATER1B8ZV94R9IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CERAMIDE NP4370DF050BIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PREZATIDE COPPER6BJQ43T1I9IACT
ACV TRIPEPTIDEO3VOU3H9VSIACT
NICOTINURIC ACID77V5315PIUIACT
HEXAPEPTIDE-10W9RS1K7T9IIACT

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
fd8192e1-5ede-45ed-b2ec-498b125c3225a4eb4054-ba66-41d6-897c-3ab93cad53db2017-12-29WarningsExact identifier
spl id: fd8192e1-5ede-45ed-b2ec-498b125c3225
spl set id: a4eb4054-ba66-41d6-897c-3ab93cad53db

Reported adverse events (FAERS/openFDA)#

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