FDA.reportPublic FDA data

Josie Maran - Argan Apothecary Daily Response Calming Treatment Lotion

Manufacturer
Cosmetic Solutions LLC
Effective date
2023-03-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:56

Label at a glance#

ProductJosie Maran - Argan Apothecary Daily Response Calming Treatment
Active ingredientSULFUR
Label structure11 sections

Indications and 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

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 3%

Purpose

OTC - PURPOSE SECTION

Acne treatment lotion

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - DO NOT USE SECTION

  • Broken skin
  • Large areas of the skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Other Information

STORAGE AND HANDLING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

Principal Display Panel - 50 mL Bottle Carton
Principal Display Panel - 50 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245607sulfur 3 % Topical LotionPSN2
245607sulfur 30 MG/ML Topical LotionSCD2
245607sulfur 3 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-4708-12025-01-30C16284748780-12cef2736-b531-d83d-e063-dadaa90ab31fJosie Maran - Argan Apothecary Daily Response Calming Treatment Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-4708-1Josie Maran - Argan Apothecary Daily Response Calming Treatment50 mL in 1 BOTTLE, PUMPLOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-4708JOSIE MARAN - ARGAN APOTHECARY DAILY RESPONSE CALMING TREATMENT (SULFUR) LOTION [COSMETIC SOLUTIONS LLC]21 package rows20230515_5c665923-e74d-4d68-974c-d1880e3584d1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-470866163-4708-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
Water059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
ARGAN OIL4V59G5UW9XIACT
OCTYLDODECYL STEAROYL STEARATE3D47Q6D93CIACT
LINOLEIC ACID9KJL21T0QJIACT
OCTYLDODECYL LACTATE8JKW8M5W35IACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
OLEIC ACID2UMI9U37CPIACT
ACACIA5C5403N26OIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
TEA TREE OILVIF565UC2GIACT
PROPANEDIOL5965N8W85TIACT
CAMELINA SATIVA SEED OIL12824X01L0IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PENTYLENE GLYCOL50C1307PZGIACT
XANTHAN GUMTTV12P4NEEIACT
DOCOSANOL9G1OE216XYIACT
SODIUM HYDROXIDE55X04QC32IIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PALMITIC ACID2V16EO95H1IACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
ARGANIA SPINOSA SEED8H7X7XB54HIACT
THYMECW657OBU4NIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
STEARIC ACID4ELV7Z65APIACT
LEVOMENOL24WE03BX2TIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
PTEROCARPUS MARSUPIUM BARKB6227M1TS0IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
LINOLENIC ACID0RBV727H71IACT
CALCIUM GLUCONATESQE6VB453KIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
03b24da1-a4f6-43d1-a754-967781dac6d45c665923-e74d-4d68-974c-d1880e3584d12023-03-13WarningsExact identifier
spl id: 03b24da1-a4f6-43d1-a754-967781dac6d4
spl set id: 5c665923-e74d-4d68-974c-d1880e3584d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.