HARMON FACE VALUES ALL-DAY SKIN RELIEF MOISTURIZING- dimethicone lotion
HARMON STORES, 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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Harmon Face Values All-Day Skin Relief Moisturizing Lotion

Active ingredients

Dimethicone 1.2%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only

When using this product

• do not get into eyes

Do not use on

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

condition worsens
symptoms last more than seven days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

apply as needed to hands or body when skin feels dry or irritated

Other Information

• may stain some fabrics

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, benzyl alcohol, avena sativa (oat) kernel oil, steareth-20, avena sativa (oat) kernel extract, butyrospermum parkii (shea) butter, potassium sorbate, sodium chloride

Label

42286E1F1

HARMON FACE VALUES ALL-DAY SKIN RELIEF MOISTURIZING
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63940-089
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SHEA BUTTER (UNII: K49155WL9Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
OATMEAL (UNII: 8PI54V663Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT (UNII: Z6J799EAJK)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63940-089-43	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/16/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/16/2017

Labeler - HARMON STORES, INC. (804085293)