ACNE MOISTURIZER- salicylic acid cream

Acne Moisturizer by

Drug Labeling and Warnings

Acne Moisturizer by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Salicylic Acid (1.0%)..........Acne Treatment

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

For treatment of acne

WARNINGS

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

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

WHEN USING

When using this product

Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Other Ingredients:

Aqua, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cetearyl Alcohol, Olea Europaea (Olive) Fruit Oil, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Glucoside, Xanthan Gum, Tocopheryl Acetate (Vitamin E), Disodium EDTA, Avena Sativa (Oat) Kernel Flour, Caffeine, *CO Aloe Barbadensis Leaf Powder, Sodium Hyaluronate (Hyaluronic Acid), Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Phenoxyethanol, Ethylhexylglycerin, Fragrance. *CO – Organic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE MOISTURIZER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9907
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 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9907-1	45 mL in 1 JAR; Type 0: Not a Combination Product	11/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/19/2023

Labeler - Spa de Soleil (874682867)

Registrant - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9907)