ACNE BIOTIC MOISTURIZER- salicylic acid lotion

Acne Biotic Moisturizer by

Drug Labeling and Warnings

Acne Biotic Moisturizer by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Salicylic Acid (0.5%)

Purpose

Acne treatment

Use

For the treatment of acne

Warnings

For external use only

Do not use

• In or near eyes. If contact occurs, flush thoroughly with water.
• If irritation or redness develops, discontinue use.

When using this product

• Apply to affected areas only.
• Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water/Aqua/Eau, Butylene Glycol, Propanediol, Niacinamide, Octyldodecanol, Ethylhexyl Olivate, Glycerin, Erythritol, Inulin, Cetearyl Olivate, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Citrus Limon (Lemon) Peel Oil, Salvia Sclarea (Clary) Oil, Hydrolyzed Jojoba Esters, Morinda Citrifolia Fruit Extract, Leptospermum Scoparium Branch/Leaf Oil, Phaeodactylum Tricornutum Extract, Magnolia Officinalis Bark Extract, Piper Nigrum (Pepper) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol, Xylitol, Squalane, Caprylyl Glycol, Lecithin, Glutamic Acid, Polyquaternium-80, Didecyldimonium Chloride, Methylpropanediol, Sorbitan Olivate, Tetrasodium Glutamate Diacetate, Citric Acid, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Caprylic Acid, Linalool, Limonene.

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

acne
biotic
moisturizer

daily acne-
targeting gel

dermalogica

Active Clearing

1.7 US FL OZ / 50 mL ℮

INGREDIENTS AND APPEARANCE

ACNE BIOTIC MOISTURIZER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Propanediol (UNII: 5965N8W85T)
Niacinamide (UNII: 25X51I8RD4)
Octyldodecanol (UNII: 461N1O614Y)
Ethylhexyl Olivate (UNII: HTC7G3S2PV)
Glycerin (UNII: PDC6A3C0OX)
Erythritol (UNII: RA96B954X6)
Inulin (UNII: JOS53KRJ01)
Cetearyl Olivate (UNII: 58B69Q84JO)
Sorbitan Olivate (UNII: MDL271E3GR)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
Glutamic Acid (UNII: 3KX376GY7L)
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
NONI FRUIT (UNII: 7829X3G2X5)
Methylpropanediol (UNII: N8F53B3R4R)
Xylitol (UNII: VCQ006KQ1E)
Caprylic Acid (UNII: OBL58JN025)
Squalane (UNII: GW89575KF9)
Caprylyl Glycol (UNII: 00YIU5438U)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Polyquaternium-80 (UNII: 3N8LGV97HR)
MANUKA OIL (UNII: M6QU9ZUH2X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDIN OIL (UNII: 9RES347CKG)
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
BLACK PEPPER (UNII: KM66971LVF)
ROSEMARY OIL (UNII: 8LGU7VM393)
Didecyldimonium Chloride (UNII: JXN40O9Y9B)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
Sodium Hydroxide (UNII: 55X04QC32I)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-350-02	1 in 1 CARTON	02/01/2025
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-350-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	02/01/2025
3	NDC: 68479-350-05	1 in 1 CARTON	02/01/2025
3		7 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	02/01/2025

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-350)