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

ATO STANDARD PREMIUM MILDCREAM by

Drug Labeling and Warnings

ATO STANDARD PREMIUM MILDCREAM by is a Otc medication manufactured, distributed, or labeled by TIMEBIO Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ATO STANDARD PREMIUM MILDCREAM 
butyrospermum park2 shea butter, centella asiatica extract, ceramide np cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81160-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) (CENTELLA ASIATICA WHOLE - UNII:7M867G6T1U)	CENTELLA ASIATICA WHOLE	0.005 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y)	SHEA BUTTER	3 g  in 100 g
CERAMIDE NP (UNII: 4370DF050B) (CERAMIDE NP - UNII:4370DF050B)	CERAMIDE NP	0.0018 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81160-201-01	75 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2021

Labeler - TIMEBIO Co., Ltd (695743093)

Registrant - TIMEBIO Co., Ltd (695743093)

Establishment
Name	Address	ID/FEI	Business Operations
TIMEBIO Co., Ltd		695743093	manufacture(81160-201)