FDA.reportPublic FDA data

Photocil

Manufacturer
Jupiter Wellness, Inc. | Health Specialty
Effective date
2023-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:38:38

Label at a glance#

ProductPhotocil
Active ingredientDIMETHICONE
Label structure13 sections

Indications and uses

helps prevent and temporarily protects and relieves chapped or cracked skin prone to psoriasis and vitiligo.

Dosage and administration

consult dermatologist prior to use apply as needed apply Photocil cream to affected skin area(s) allow affected area(s) of skin to receive direct exposure to daylight following application of Photocil cream for 20 minutes protect unaffected skin from sun exposure

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects and relieves chapped or cracked skin prone to psoriasis and vitiligo.

Warnings

WARNINGS SECTION

For external use only

This product is not a sunscreen or sunblock. Prolonged sun exposure can cause sunburn, skin damage, and cancer. Healthy (non-psoriasis or vitiligo affected) skin should be covered with clothing or protected with a sunscreen.

OTC - WHEN USING SECTION

  • When using this product do not get into eyes
  • If swallowed, get medical help or contact a Poison Control Center right away

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens
  • symptoms do not improve after more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Directions

DOSAGE & ADMINISTRATION SECTION

  • consult dermatologist prior to use
  • apply as needed
  • apply Photocil cream to affected skin area(s)
  • allow affected area(s) of skin to receive direct exposure to daylight following application of Photocil cream for 20 minutes
  • protect unaffected skin from sun exposure

Inactive ingredients

INACTIVE INGREDIENT SECTION

1,2-hexanediol, 2-ethylhexyl benzoate, caprylyl glycol, carbomer interpolymer type a (allyl sucrose crosslinked), cetostearyl alcohol,

dimethyl isosorbide, edetate disodium, glucosyl hesperidin, glyceryl mono-stearate, PEG-100 stearate, polyoxyl 20 cetostearyl ether,

propanediol, sesame oil, trolamine, water

OTC - QUESTIONS SECTION

561.244.7100

RECENT MAJOR CHANGES SECTION

  • Uses
  • Directions for Use

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Photocil Cream - Psoriasis and VitiligoPhotocil Cream - Psoriasis and Vitiligo

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82301-004-012024-01-30C16284748780-1f386c64a-23dd-0266-e053-dadaa90a7c1aDrug Facts
82301-004-012023-01-31C16284748780-1f386c64a-23dd-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82301-00482301-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
2-ETHYLHEXYL BENZOATER63ZWW1A13IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
EDETATE DISODIUM7FLD91C86KIACT
GLUCOSYL HESPERIDIN432C95B6YEIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPANEDIOL5965N8W85TIACT
SESAME OILQX10HYY4QVIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB

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
14bc4bb2-33c0-0d35-e063-6394a90a76c0d203badb-b9d0-f64b-e053-2995a90a7f202024-03-28WarningsExact identifier
spl set id: d203badb-b9d0-f64b-e053-2995a90a7f20

Reported adverse events (FAERS/openFDA)#

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