Photocil by Jupiter Wellness, Inc. / Health Specialty Drug Facts

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.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses

• helps protect the appearance of the skin from the effects of psoriasis
• 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 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: 82301-002
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
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82301-002-01	1 in 1 CARTON	10/05/2021
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 final	part347	10/05/2021	11/29/2021

Labeler - Jupiter Wellness, Inc. (118320452)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty		794053863	manufacture(82301-002)

Revised: 11/2021

Document Id: d1f3e0db-07b0-5f83-e053-2995a90a0e22

34390-5

Set id: cd9cc6ea-aae5-3970-e053-2995a90a5705

Version: 2

Effective Time: 20211129