XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING- dimethicone lotion 
Rejoice International

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XtraCare Skin Relief Oatmeal Daily Moisturizing

Active Ingredient                  Purpose

Dimethicone 1/3% ...... Skin Protectant

XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion

dimethicone skin protectant

with soothing oat essence

To Protect & Relieve Dry Skin

12 fl oz (354 mL)

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

Use help prevent and temporarily protets 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.

Directions  apply liberally as often as needed.

Other information Store at room temperature.

DISTRIBUTED BY: 

REJOICE INTERNATIONAL INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168 USA

MADE IN CHINA

Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.

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XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OAT (UNII: Z6J799EAJK)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-054-01227 g in 1 BOTTLE; Type 0: Not a Combination Product11/26/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01611/26/2013
Labeler - Rejoice International (078741245)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(57337-054)

Revised: 2/2024
Document Id: 126dde68-9fa5-3cac-e063-6394a90aec7e
Set id: 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907
Version: 3
Effective Time: 20240228
 
Rejoice International