HARMON FACE VALUES REVITALIZING DAY CREAM- ensulizole, octinoxate cream

Harmon Face Values by

Drug Labeling and Warnings

Harmon Face Values by is a Otc medication manufactured, distributed, or labeled by Emilia Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Ensulizone, 1.7%

Octinoxate, 7.5%

PURPOSE

Purpose

Sunscreen

Sunscreen

INDICATIONS & USAGE

Uses  helps prevent sunburn

WARNINGS

WarningsSkin Cancer/Skin Aging Alert: Spending time in the sun increases your

risk of skin cancer and early sking aging. This product has been shown only to help

prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on  damaged or broken skin

When using this product keep out of eyes. Rinse with wter to remove.

Stop use and ask a doctor  if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Control Center right away.

DOSAGE & ADMINISTRATION

Directions  apply liberally 15 minutes before sun exposure  reapply at least every 2

hours  use a water resistant sunscreen if swimming or sweating  children under 6

months of age: ask a doctor

STORAGE AND HANDLING

Other information  protect the product in this container from excessive heat

and direct sun

INACTIVE INGREDIENT

Inactive ingredients water, cyclopentasiloxane, glycerin, mineral oil,

titanium dioxide, alumina, simethicone, glyceryl stearate, PEG-100 stearate,

myristyl myristate, triethanolamine, cetearyl alcohol, stearic acid, palmitic acid, PEG-20

stearate, phenoxyehtanol, ethylhexylglycerin, mannitol, cyclodextrin, yeast extract,

disodium succinate, panthenol (pro-vitamin B-5), polyacrylamide, C13-14 isoparaffin,

laureth-7, honey extract, soluble collagen, hydrolyzed elastin, sodium PCA, serine,

glycogen, butylene glycol, carbomer, polysorbate 20, palmitoyl tripeptide-1,

palmitoyl tripeptide-7, tocopherol acetate (vitamin E), polyacrylate-13,

polyisobutene, fragrance, allantoin, rosa canina fruit oil, salicylic acid, jasminum

officinale (jasmine) flower extract, glycine soja (soybean) protein, yellow 5

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARMON FACE VALUES  REVITALIZING DAY CREAM
ensulizole, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68975-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.19 g  in 70 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.25 g  in 70 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
TROLAMINE (UNII: 9O3K93S3TK)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-20 STEARATE (UNII: NBX892EA57)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MANNITOL (UNII: 3OWL53L36A)
BETADEX (UNII: JV039JZZ3A)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PANTHENOL (UNII: WV9CM0O67Z)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
HONEY (UNII: Y9H1V576FH)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SERINE (UNII: 452VLY9402)
GLYCOGEN (UNII: 309GSC92U1)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ALLANTOIN (UNII: 344S277G0Z)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SALICYLIC ACID (UNII: O414PZ4LPZ)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
SOY PROTEIN (UNII: R44IWB3RN5)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68975-200-70	1 in 1 CARTON	06/26/2017
1		70 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/25/2017

Labeler - Emilia Resources, LLC (079378421)