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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated November 17, 2021

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)