DR. OBERON MOMS CARE OIL- dimethicone oil 
Oberon Cosmetic Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dr. OBERON MOM'S CARE OIL LOTION

dimethicone

Skin protectant

If swallowed, get medical help or contact a Poison Control Center right away

skin care for pregnant women

For external use only

Apply a thin layer of cream 2-3 times per day. Massage in circular motion.

water, momordica charantia fruit extract, glycerin, helianthus annuus sunflower seed oil, olea europaea (olive) fruit oil, caprylic capric triglyceride, butylene glycol, dipropylene glycol, glyceryl stearate, polysorbate 60, cetearyl alcohol, glycine soja (soybean) protein, aloe barbadensis leaf extract, sorbitan sesquioleate, PEG-100 stearate, biosacchharide gum-1, glyceryl caprylate, chlorphenesin, panthenol, sodium polyacrylate, hydrogenated polydecene, trideceth-6, carbomer, triethanolamine, magnolia liliflora flower extract, camellia sinensis leaf extract, scutellaria glabra (licorice) root extract, punica granatum fruit extract, allantoin,tocopheryl acetate, dipotassium gylcyrrhizate, adenosine, disodium EDTA, rh-polypeptide-1, bacillus/glutamic acid ferment filtrate, ubiquinone

image description

DR. OBERON MOMS CARE OIL 
dimethicone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52891-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) dimethicone1.5   in 150 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
MOMORDICA CHARANTIA FRUIT (UNII: UA63Y8U89U)  
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
butylene glycol (UNII: 3XUS85K0RA)  
dipropylene glycol (UNII: E107L85C40)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
polysorbate 60 (UNII: CAL22UVI4M)  
SOYBEAN (UNII: L7HT8F1ZOD)  
ALOE (UNII: V5VD430YW9)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
PEG-100 stearate (UNII: YD01N1999R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52891-101-021 in 1 CARTON
1NDC:52891-101-01150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2014
Labeler - Oberon Cosmetic Co., Ltd. (631155194)
Registrant - Oberon Cosmetic Co., Ltd. (631155194)
Establishment
NameAddressID/FEIBusiness Operations
Oberon Cosmetic Co., Ltd.631155194manufacture(52891-101)

Revised: 6/2014
Document Id: 45a35ea6-9af4-4375-b0fe-b36ed00a3a74
Set id: d4a4e200-88e8-4f59-8436-62e05d4bfcd3
Version: 1
Effective Time: 20140611
 
Oberon Cosmetic Co., Ltd.