DIMETHICONE 1 SKIN PROTECTANT- dimethicone lotion

Dimethicone 1 Skin Protectant by

Drug Labeling and Warnings

Dimethicone 1 Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

Helps prevent and temporarily protects chafed, chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather.

Warnings

For external use only.

When using this product
Do not get into eyes.

Stop use and ask a doctor if
Conditions worsens.
Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on  Deep or puncture wounds  Animal bites  Serious burns.

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

Directions

Apply as needed.

Inactive Ingredients

water, cetearyl alcohol, mineral oil, glycerin, petrolatum, ceteareth-20, propylene glycol, cetrimonium chloride, carbomer, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydoxide, avena sativa (oat) kernel flour, tocopheryl acetate, FD&C yellow no.6, FD&C yellow no.5, FD&C blue no.1

SPL UNCLASSIFIED SECTION

with natural colloidal oatmeal

protects and relieves dry skin

fragrance free

long lasting moisturizer

*Compare to Aveeno®

U Daily Moisturizing Lotion helps prevent and protect dry skin, providing temporary relief of chapping associated with dry skin. This naturally nourishing, non-greasy formula absorbs quickly, won't clog pores, and contains no added fragrance. 

U Daily Moisturizing Lotion leaves your skin soft, smooth and naturally healthy looking.

Distributed by:
Universal Distribution Center
96 Distribution Boulevard
Edison, NJ 08817

Packaging

INGREDIENTS AND APPEARANCE

DIMETHICONE 1 SKIN PROTECTANT 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-417
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OATMEAL (UNII: 8PI54V663Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-417-12	355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/17/2024

Labeler - Universal Distribution Center LLC (019180459)