Jupiter Wellness (as PLD) - Photocil (82301-001) - DELIST

Photocil by

Drug Labeling and Warnings

Photocil by is a Otc medication manufactured, distributed, or labeled by Jupiter Wellness, Inc., Health Specialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PHOTOCIL- dimethicone cream 
Jupiter Wellness, Inc.

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Jupiter Wellness (as PLD) - Photocil (82301-001) - DELIST

Active Ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses

• helps protect the appearance of the skin from the effects of dermatitis
• helps prevent and protect the skin from the external drying effects of wind, light and weather
• allows penetration of therapeutic radiation while filtering out most non-therapeutic radiation from daylight and artificial light

Warnings

For external use only

When using this product do not get into eyes

Stop use and ask doctor if

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• 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

Other information

• store at room temperature (not to exceed 2 years)

Inactive ingredients

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

Carton Label

PHOTOCIL 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82301-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.6 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLUCOSYL HESPERIDIN (UNII: 432C95B6YE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPANEDIOL (UNII: 5965N8W85T)
SESAME OIL (UNII: QX10HYY4QV)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82301-001-01	1 in 1 CARTON	10/05/2021	12/31/2023
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/05/2021	12/31/2023

Labeler - Jupiter Wellness, Inc. (118320452)

Revised: 3/2024

Document Id: 14bc483c-15bf-9ea9-e063-6294a90a80ae

34390-5

Set id: cd9c8789-b9b9-5840-e053-2995a90a1555

Version: 3

Effective Time: 20240328