FDA.reportPublic FDA data

81160-201 ATO STANDARD Premium Mild Cream

Manufacturer
TIMEBIO Co., Ltd
Effective date
2021-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:58

Label at a glance#

ProductATO STANDARD PREMIUM MILDCREAM
Active ingredientCENTELLA ASIATICA WHOLE, SHEA BUTTER, CERAMIDE NP
Label structure9 sections

Indications and uses

The unique formula protects skin by improving skin barrier and prevents moistureloss and revives skin itching due to dryness. Nutritional oil revives smoothe-feeling skin texture and helps to achieve glowing skin.

Dosage and administration

Apply daily to skin needs special care like dry skin as needed and smooth to help absorption.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

BUTYROSPERMUM PARKII (SHEA) BUTTER 3%

CENTELLA ASIATICA EXTRACT 0.005%

CERAMIDE NP 0.0018%

BETA-GLUCAN 0.01%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

DOSAGE & ADMINISTRATION SECTION

The unique formula protects skin by improving skin barrier and prevents moistureloss and revives skin itching due to dryness.

Nutritional oil revives smoothe-feeling skin texture and helps to achieve glowing skin.

Warnings

WARNINGS SECTION

Direct sunlight.

Do not use children under 3 years of age

Do not use on wounds

Warnings

OTC - STOP USE SECTION

Discontinue use if irritation occurs.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

INDICATIONS & USAGE SECTION

Apply daily to skin needs special care like dry skin as needed and smooth to help absorption.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

WATER, PROPANEDIOL, BEHENYL ALCOHOL, DICAPRYLYL ETHER, VEGETABLE OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POTASSIUM CETYL PHOSPHATE, 1,2-HEXANEDIOL, METHYL TRIMETHICONE, GLYCERYL STEARATE SE, LAMINARIA JAPONICA EXTRACT, ECLIPTA PROSTRATA LEAF EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, ACMELLA OLERACEA EXTRACT, ULMUS DAVIDIANA ROOT EXTRACT, AMARANTHUS CAUDATUS SEED EXTRACT, HYDROGENATED LECITHIN, WATER (and) HUMAN CORD BLOOD PROGENITOR CELL EXOSOMES, HYDROGENATED PALM GLYCERIDES, CETEARYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ARGININE, BUTYLENE GLYCOL, XANTHAN GUM, SODIUM STEAROYL GLUTAMATE, DISODIUM EDTA,FRUCTOOLIGOSACCHARIDES, BETA-GLUCAN, CHOLESTEROL, HYDROLYZED HYALURONIC ACID, SACCHARIDE ISOMERATE, SODIUM CITRATE, CITRIC ACID, FRAGRANCE, ETHYLHEXYLGLYCERIN

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75g 81160-201-01 ATO STANDARD Premium Mild Cream75g 81160-201-01 ATO STANDARD Premium Mild Cream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
81160-201-012023-01-30C16284748780-1f386c649-c681-0266-e053-dadaa90a7c1a81160-201 ATO STANDARD Premium Mild Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81160-201-01ATO STANDARD PREMIUM MILDCREAM75 g in 1 TUBECREAM753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81160-201ATO STANDARD PREMIUM MILDCREAM (BUTYROSPERMUM PARK2 SHEA BUTTER, CENTELLA ASIATICA EXTRACT, CERAMIDE NP) CREAM [TIMEBIO CO., LTD]3Legacy NDC, 1 package rows20211119_b59a75f8-df1c-1cb3-e053-2a95a90a3e55.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81160-20181160-201-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCOSANOL9G1OE216XYIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ECLIPTA PROSTRATA LEAFH86R96580EIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
CENTELLA ASIATICA WHOLE7M867G6T1UACTIB
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
CORN OIL8470G57WFMIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
LAMINARIA JAPONICAWE98HW412BIACT
FIGTGD87RII2UIACT
CHOLESTEROL97C5T2UQ7JIACT
SHEA BUTTERK49155WL9YACTIB
AMARANTHUS CAUDATUS SEEDFJ722PPQ9MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
CERAMIDE NP4370DF050BACTIB
GREEN TEA LEAFW2ZU1RY8B0IACT
ACMELLA OLERACEA FLOWERING TOP1O11RD9U53IACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DICAPRYLYL ETHER77JZM5516ZIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ULMUS DAVIDIANA ROOTURQ79U8261IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ARGININE94ZLA3W45FIACT
SACCHARIDE ISOMERATEW8K377W98IIACT

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
d108b193-c9c1-0340-e053-2a95a90ad775b59a75f8-df1c-1cb3-e053-2a95a90a3e552021-11-17WarningsExact identifier
spl id: d108b193-c9c1-0340-e053-2a95a90ad775
spl set id: b59a75f8-df1c-1cb3-e053-2a95a90a3e55

Reported adverse events (FAERS/openFDA)#

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