JOSIE MARAN - ARGAN APOTHECARY DAILY RESPONSE CALMING TREATMENT- sulfur lotion

Josie Maran - Argan Apothecary Daily Response Calming Treatment by

Drug Labeling and Warnings

Josie Maran - Argan Apothecary Daily Response Calming Treatment by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sulfur 3%

Purpose

Acne treatment lotion

Uses

• For the treatment of acne
• Helps clear up, dry, and reduce the severity of acne blemishes, acne pimples, blackheads, or whiteheads and allows skin to heal
• Penetrates pores to help prevent the development of new acne blemishes, acne pimples, blackheads, or whiteheads

Warnings

For external use only.

When using this product

• Skin irritation and dryness is 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.
• Apply only to areas with acne.

Do not use on

• Broken skin
• Large areas of the skin

Keep out of reach of children.

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

Other Information

• Store in a cool, dry place. Keep cap closed when not in use.

Directions

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

Aqua (Water)1, Caprylic/Capric Triglyceride1, Glycerin1, Argania Spinosa (Argan) Kernel Oil2, Octyldodecyl Stearoyl Stearate, Octyldodecyl Lactate, Linoleic Acid1, lsostearyl lsostearate1, Sorbitan Laurate1, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters1, Capryloyl Glycine1, Oleic Acid1, Acacia Senegal Gum1, Dimethyl lsosorbide, Melaleuca Alternifolia (Tea Tree) Leaf Oil1, Propanediol1, Camelina Sativa (Gold-of-Pleasure) Seed Oil1, Arachidyl Alcohol1, Cetearyl Alcohol1, Glyceryl Stearate1, Pentylene Glycol1, Xanthan Gum1, Behenyl Alcohol1, Sodium Hydroxide, Arachidyl Glucoside1, Palmitic Acid1, Sodium Stearoyl Lactylate1, Argania Spinosa (Argan) Kernel Extract1, Thymus Vulgaris (Thyme) Flower/Leaf/Stem Extract1, Phenethyl Alcohol1, Stearic Acid1, Bisabolol1, Lycium Barbarum (Goji Berry) Fruit Extract1, Phytosphingosine, Pterocarpus Marsupium (Indian Kino Tree) Bark Extract1, Lecithin1, Tetrasodium Glutamate Diacetate, Linolenic Acid1, Calcium Gluconate, Gluconolactone, Sodium Benzoate, Caprylic Acid, Tocopherol1, Sodium Carbonate, Sodium Chloride, Ubiquinone, D-Limonene.

1 NATURALLY-DERIVED.

2 ORGANIC

Questions or Comments?

Call us at (888) 215-8733 or visit us at www.josiemaran.com Monday to Friday 6am-6pm PST

SPL UNCLASSIFIED SECTION

Dist. by Josie Maran Cosmetics, LLC
Hollywood, CA 90038

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

JOSIE MARAN
ARGAN APOTHECARY

Daily Response
Calming Treatment
Lotion

Medicinal Botanicals
and Sulfur for Adult Acne,
Sensitive Skin, and Pores

50 mL 1.7 fl. oz.

INGREDIENTS AND APPEARANCE

JOSIE MARAN - ARGAN APOTHECARY DAILY RESPONSE CALMING TREATMENT 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-4708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
ARGAN OIL (UNII: 4V59G5UW9X)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
OCTYLDODECYL LACTATE (UNII: 8JKW8M5W35)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
OLEIC ACID (UNII: 2UMI9U37CP)
ACACIA (UNII: 5C5403N26O)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
TEA TREE OIL (UNII: VIF565UC2G)
PROPANEDIOL (UNII: 5965N8W85T)
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
XANTHAN GUM (UNII: TTV12P4NEE)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
THYME (UNII: CW657OBU4N)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PTEROCARPUS MARSUPIUM BARK (UNII: B6227M1TS0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
LINOLENIC ACID (UNII: 0RBV727H71)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CAPRYLIC ACID (UNII: OBL58JN025)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CARBONATE (UNII: 45P3261C7T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
UBIDECARENONE (UNII: EJ27X76M46)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-4708-1	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/15/2023

Labeler - Cosmetic Solutions LLC (807907928)