DR. OBERON MOMS CARE BODY 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 BODY OIL

Dimethicone

Skin protectant

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away

skin care for pregnant women

Warnings For external use only Do not use on Deep or puncture wounds, Animal bites, Serious burns When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor If your skin is red, inflamed, itchy or irritated.

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

Cyclopentasiloxane, Cyclohexasiloxane, Dimethiconol, Caprylic/ capric triglyceride, Mink oil, Camellia Japonica Seed oil, Phenoxyethanol, Bixa Orellana Seed oil, Tocopheryl acetate, Perfume

oberon 3

DR. OBERON MOMS CARE BODY OIL 
dimethicone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52891-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE26   in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
TRICAPRIN (UNII: O1PB8EU98M)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BIXA ORELLANA SEED OIL (UNII: 3R3HS2KR6P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52891-102-021 in 1 CARTON
1NDC:52891-102-01100 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/12/2014
Labeler - Oberon Cosmetic Co., Ltd. (631155194)
Registrant - Oberon Cosmetic Co., Ltd. (631155194)
Establishment
NameAddressID/FEIBusiness Operations
Oberon Cosmetic Co., Ltd.631155194manufacture(52891-102)

Revised: 6/2014
Document Id: 86aafc39-2b4a-4e6e-85ac-50c08dc248b7
Set id: a5be174b-be3a-4c33-ac23-7b1d7a3bb5cc
Version: 1
Effective Time: 20140612
 
Oberon Cosmetic Co., Ltd.