ALL PURPOSE HEALING BABY CREAM- colloidal oatmeal cream

All Purpose Healing Baby Cream by

Drug Labeling and Warnings

All Purpose Healing Baby Cream by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Oatmeal 1%

Purpose

Skin Protectant

Warnings

For external use only.

When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop using this product and ask a doctor if condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Directions: For mild to moderate eczema on body, apply as needed or as directed by a physician.

Uses:

Uses Temporarily protects and helps relieve minor skin itching and irritation due to eczema.

Inactive Ingredients:

Inactive ingredients: Aqua, Isopropyl Palmitate, Glycerin, Ricinus Communis (Castor) Seed Oil, Cetyl Alcohol, Polysorbate 20, Helianthus Annuus (Sunflower) Seed Oil, Distearyldimonium Chloride, Avena Sativa (Oat) Kernel Oil, Hydroxyethylcellulose, Panthenol, Hydrogenated Castor Oil, Beeswax, Dimethicone, Copernicia Cerifera (Carnauba) Wax, Sodium Hydroxide, *CO Helianthus Annuus (Sunflower Oil), Tocopheryl Acetate (Vitamin E), Prunus Armeniaca (Apricot) Kernel Oil, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, Gluconolactone, Sodium Benzoate.
*CO Certified Organic

Warning

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALL PURPOSE HEALING BABY CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-3301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.18 mg  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COPERNICIA CERIFERA (CARNAUBA) WAX (UNII: R12CBM0EIZ)
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERIN (UNII: PDC6A3C0OX)
PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT (UNII: 75356789IW)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
BEESWAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PANTHENOL (UNII: WV9CM0O67Z)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
AVENA SATIVA (OAT) KERNEL OIL (UNII: 3UVP41R77R)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-3301-1	118 mL in 1 CANISTER; Type 0: Not a Combination Product	07/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/13/2025

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-3301)