STABILIZING REPAIR SERUM- oatmeal liquid

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (w/w)

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

• Rashes
• Eczema

Warnings

For external use only

When using this product

• Do not get into eyes. Rinse with water to remove.

Stop use and ask a doctor if

• conditions worsen
• symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

Directions

• Apply as needed.

Inactive ingredients

Water, Butylene Glycol, Squalane, Glycerin, Hexyldecanol, Propanediol, Dimethicone, Maltodextrin, Pentylene Glycol, Hydroxyacetophenone, Dipotassium Glycyrrhizate, Avena Sativa (Oat) Kernel Extract, Albatrellus Confluens (Mushroom) Extract, Brassica Campestris (Rapeseed) Sterols, Myrothamnus Flabellifolia Leaf/Stem Extract, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Caprylyl Glycol, Allantoin, Cetylhydroxyproline Palmitamide, Beta-Glucan, Caprylic/Capric Triglyceride, Bisabolol, Hydrogenated Lecithin, 1,2-Hexanediol, Physalis Pubescens Fruit Juice, Tetrasodium Glutamate Diacetate, Polysorbate 20, Sorbitan Isostearate, Citric Acid, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Menthyl Lactate, Stearic Acid, Calcium Chloride, Sodium Benzoate.

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton

stabilizing
repair
serum

for eczema-prone,
reactive, and
irritated skin

relief for face
and body
with 1% colloidal
oat skin protectant

UltraCalming

0.24 US FL OZ / 7 mL ℮

dermalogica

INGREDIENTS AND APPEARANCE

STABILIZING REPAIR SERUM 
oatmeal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-460
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Squalane (UNII: GW89575KF9)
Glycerin (UNII: PDC6A3C0OX)
Hexyldecanol (UNII: 151Z7P1317)
Propanediol (UNII: 5965N8W85T)
Dimethicone (UNII: 92RU3N3Y1O)
Maltodextrin (UNII: 7CVR7L4A2D)
Pentylene Glycol (UNII: 50C1307PZG)
Hydroxyacetophenone (UNII: G1L3HT4CMH)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
OAT (UNII: Z6J799EAJK)
ALBATRELLUS CONFLUENS FRUITING BODY (UNII: 7UVG8A4DP0)
RAPESEED STEROL (UNII: B46B6DD20U)
MYROTHAMNUS FLABELLIFOLIA TOP (UNII: J65B6VMC9D)
GINGER (UNII: C5529G5JPQ)
Tocopherol (UNII: R0ZB2556P8)
Caprylyl Glycol (UNII: 00YIU5438U)
Allantoin (UNII: 344S277G0Z)
Cetylhydroxyproline Palmitamide (UNII: 74ONU0S62G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LEVOMENOL (UNII: 24WE03BX2T)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
1,2-Hexanediol (UNII: TR046Y3K1G)
Physalis Pubescens Fruit Juice (UNII: GM2TDN9DZI)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
Stearic Acid (UNII: 4ELV7Z65AP)
Calcium Chloride (UNII: M4I0D6VV5M)
Sodium Benzoate (UNII: OJ245FE5EU)
Farnesol (UNII: EB41QIU6JL)
Citral (UNII: T7EU0O9VPP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
Geraniol (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
Pinene (UNII: 996299PUKB)
Terpineol (UNII: R53Q4ZWC99)
Isoeugenol (UNII: 5M0MWY797U)
Kaolin (UNII: 24H4NWX5CO)
ZINC PIDOLATE (UNII: C32PQ86DH4)
CHAMOMILE (UNII: FGL3685T2X)
Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-460-20	1 in 1 CARTON	10/16/2025
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-460-50	1 in 1 CARTON	10/16/2025
2		7 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68479-460-40	100 mL in 1 TUBE; Type 0: Not a Combination Product	10/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M016	10/16/2025

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-460)