ATO STANDARD PREMIUM MILDCREAM- butyrospermum park2 shea butter, centella asiatica extract, ceramide np cream 
TIMEBIO Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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81160-201 ATO STANDARD Premium Mild Cream

Active Ingredient

BUTYROSPERMUM PARKII (SHEA) BUTTER 3%

CENTELLA ASIATICA EXTRACT 0.005%

CERAMIDE NP 0.0018%

BETA-GLUCAN 0.01%

Purpose

Skin protectant

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.

Warnings

Direct sunlight.

Do not use children under 3 years of age

Do not use on wounds

Warnings

Discontinue use if irritation occurs.

Warnings

Keep out of reach of children.

Directions

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

Inactive Ingredient

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

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

ATO STANDARD PREMIUM MILDCREAM 
butyrospermum park2 shea butter, centella asiatica extract, ceramide np cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81160-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA WHOLE - UNII:7M867G6T1U) CENTELLA ASIATICA WHOLE0.005 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER3 g  in 100 g
CERAMIDE NP (UNII: 4370DF050B) (CERAMIDE NP - UNII:4370DF050B) CERAMIDE NP0.0018 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
CORN OIL (UNII: 8470G57WFM)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
LAMINARIA JAPONICA (UNII: WE98HW412B)  
FIG (UNII: TGD87RII2U)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ARGININE (UNII: 94ZLA3W45F)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81160-201-0175 g in 1 TUBE; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2021
Labeler - TIMEBIO Co., Ltd (695743093)
Registrant - TIMEBIO Co., Ltd (695743093)
Establishment
NameAddressID/FEIBusiness Operations
TIMEBIO Co., Ltd695743093manufacture(81160-201)

Revised: 11/2021
Document Id: d108b193-c9c1-0340-e053-2a95a90ad775
Set id: b59a75f8-df1c-1cb3-e053-2a95a90a3e55
Version: 3
Effective Time: 20211117
 
TIMEBIO Co., Ltd