Body Seal Ultra Reparing by Skin Ps Brands SLMD Body Seal

Drug Details [pdf]

BODY SEAL ULTRA REPARING- oatmeal cream
Skin Ps Brands

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.

----------

SLMD Body Seal

Active Ingredient

Colloidal Oatmeal 1.0%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to

eczema
rashes

Warnings

For External Use Only

When using this product

Avoid contact with eyes

Stop Use and ask a doctor if

Condition worsens
symptom 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 right away

Directions

Apply directly to affected areas of skin

Other Information

Store in a cool, dry place

Inactive Ingredients

Dimethicone,Water, Dimethicone, Butylene Glycol, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Niacinamide, Oryza Sativa (Rice) Bran Oil, Avena Sativa (Oat) Kernel Flour, Potassium Cetyl Phosphate, 1,2-Hexandiol, Caprylyl Glycol, Aluminum Starch Octenylsuccinate, Carbomer, Vitis Vinifera (Grape) Seed Oil, Hydrogenated Palm Glycerides, Aminomethyl Propanol, Sodium PCA, Hordeum Distichon (Barley) Extract, Panthenol, Tocopheryl Acetate, Phellodendron Amurense Bark Extract, Santalum Album (Sandalwood) Extract, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Dipotassium Glycyrrhizate, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea ) Butter, Pentylene Glycol, Squalane, Ceramide NP, Sodium Hyaluronate.

Body SealUC

BODY SEAL ULTRA REPARING
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73318-4180
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
NIACINAMIDE (UNII: 25X51I8RD4)
RICE BRAN OIL (UNII: LZO6K1506A)
OAT KERNEL OIL (UNII: 3UVP41R77R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CARBOMER 980 (UNII: 4Q93RCW27E)
GRAPE SEED OIL (UNII: 930MLC8XGG)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BARLEY (UNII: 5PWM7YLI7R)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
SANDALWOOD (UNII: 3641YW25N2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE (UNII: QHQ97HF0PY)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SQUALANE (UNII: GW89575KF9)
ceramide NP (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 73318-4180-2	1 in 1 CARTON	08/25/2020
1	NDC: 73318-4180-1	180 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/25/2020	11/30/2022

Labeler - Skin Ps Brands (081085221)

Revised: 6/2022

Document Id: 2712d642-3952-4ac5-afa3-5f2721e34156

Set id: bc6da44b-deaf-490b-b275-434769621a7d

Version: 6

Effective Time: 20220607