SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING- dimethicone lotion 
Volume Distributors, Inc.

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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SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING LOTION

SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING LOTION


Active Ingredient

Dimethicone.............1.3%

Purpose

Skin protectant

Use

Help prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings

For external use only.

When using this product

avoid contact with eyes.  In case of eye contact, flush with water.

Stop use and ask a doctor if

condition worsens.  Symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

apply liberally as often as needed.

Other information

Store at room temperature.

Inactive ingredients

Water, Paraffinum Liquidum, Isopropyl Myristate, Glycerin, Glyceryl Stearate, Propylene Glycol, PEG-100 Stearate, Polyacrylamide, Cetyl Alcohol, Fragrance, DMDM Hydantoin, STearyl Alcohol, C13-14 Isoparaffin, Laureth-7, Disodium EDTA, Methylparaben, Propylparaben, Avena Sativa Kernel Extract.

SPA MYSTIQUE  Skin Relief Oatmeal Daily Moisturizing Lotion  dimethicone skin protectant with soothing oat essence  To protect and Relieve Dry Skin  8 fl. oz (235 mL)    MADE IN CHINA   Spa Mystique Vernon, CA 90058 USA   Spa Mystique is a trademark of Volume Brands International   Vist VolumeBrandIint.com

SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING LOTION 8OZ/235ml (50523-100-08)

Oatmeal Lotion

SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
OAT (UNII: Z6J799EAJK)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50523-100-081 in 1 CARTON
1235 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/20/2012
Labeler - Volume Distributors, Inc. (002029544)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(50523-100)

Revised: 8/2014
Document Id: 5bc72876-5a5a-4e1a-9854-e31cebeac925
Set id: 86ebc90e-b508-47db-a1c7-2c578c5a942b
Version: 2
Effective Time: 20140804
 
Volume Distributors, Inc.