Baby XtraCare Oatmeal

Manufacturer: Rejoice International | China Ningbo Shangge Cosmetic Technology Corp
Effective date: 2025-01-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:53:30

Label at a glance#

ProductBaby XtraCare Oatmeal

Active ingredientDIMETHICONE

Label structure9 sections

Contacts and useful links#

PhoneLabel contact1-855-345-5575

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Dimethicone 1.2% ............................ Skin Protectant

OTC - PURPOSE SECTION

Use

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Baby XtraCare®

Oatmeal Daily Moisturizing Lotion

Lightly Scented

Dimethicon Skin Protectant with Natural Oat Extract

Helps Soothe & Soften Baby's Skin

12 FL OZ (354 mL)

DOSAGE & ADMINISTRATION SECTION

Directions

Apply liberally as often as needed.

WARNINGS SECTION

Warnings

For extenal 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 7days or clear up and occur again within a few days.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

OTHER SAFETY INFORMATION

Other Information Store at room temperature.

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 U.S.A.

MADE IN CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8oz label image

12oz label image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
876980	dimethicone 1.2 % Topical Lotion	PSN	2
876980	dimethicone 12 MG/ML Topical Lotion	SCD	2
876980	dimethicone 1.2 % Topical Lotion	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-070-01	2025-01-23	C162847	48780-1	9d75b9d0-2cfb-f424-e053-dadaa90a57ce	0049462b-ff31-440f-9244-b61153625bca
57337-070-02	2025-01-23	C162847	48780-1	9d75b9d0-2cfb-f424-e053-dadaa90a57ce	0049462b-ff31-440f-9244-b61153625bca
57337-070-01	2020-01-31	C162847	48780-1	9d75b9d0-2cfb-f424-e053-dadaa90a57ce	0049462b-ff31-440f-9244-b61153625bca
57337-070-02	2020-01-31	C162847	48780-1	9d75b9d0-2cfb-f424-e053-dadaa90a57ce	0049462b-ff31-440f-9244-b61153625bca

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-070-01	Baby XtraCare Oatmeal	227 g in 1 BOTTLE	LOTION	227		2
57337-070-02	Baby XtraCare Oatmeal	354 g in 1 BOTTLE	LOTION	354		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-070	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	2	Current NDC, Legacy NDC, 2 package rows	20250125_0049462b-ff31-440f-9244-b61153625bca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
AVENA SATIVA WHOLE	INACTIVE INGREDIENT	5P8D0Z74RG	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYACRYLAMIDE (10000 MW)	INACTIVE INGREDIENT	E2KR9C9V2I	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

Baby XtraCare Oatmeal
Dimethicone
WATER
PETROLATUM
MINERAL OIL
GLYCERIN
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL
PEG-100 STEARATE
POLYACRYLAMIDE (10000 MW)
CETYL ALCOHOL
AVENA SATIVA WHOLE
DMDM HYDANTOIN
STEARYL ALCOHOL
C13-14 ISOPARAFFIN
LAURETH-7
EDETATE DISODIUM
ALOE VERA LEAF
METHYLPARABEN
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57337-070	57337-070-01, 57337-070-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
PETROLATUM	4T6H12BN9U	IACT
MINERAL OIL	T5L8T28FGP	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PEG-100 STEARATE	YD01N1999R	IACT
POLYACRYLAMIDE (10000 MW)	E2KR9C9V2I	IACT
CETYL ALCOHOL	936JST6JCN	IACT
AVENA SATIVA WHOLE	5P8D0Z74RG	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
LAURETH-7	Z95S6G8201	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
DMDM HYDANTOIN	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
DMDM HYDANTOIN	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
DMDM HYDANTOIN	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baby XtraCare Oatmeal	DIMETHICONE	Rejoice International	0049462b-ff31-440f-9244-b61153625bca	2025-01-23	Warnings	Exact identifier ndc (package): 57337-070-01 ndc (package): 57337-070-02 ndc (product): 57337-070 ndc11 (package): 57337007001 ndc11 (package): 57337007002 spl id: 2c6a4461-23ef-636b-e063-6294a90a1f2a spl set id: 0049462b-ff31-440f-9244-b61153625bca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.