Harmon Face Values Revitalizing Day Cream: Package Insert and Label Information

HARMON FACE VALUES REVITALIZING DAY CREAM- ensulizole and octinoxate cream
Emilia Resources, LLC

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.

Active ingredients

Ensulizone, 1.7%

Octinoxate, 7.5%

Purpose

Sunscreen

Sunscreen

Uses •helps prevent sunburn

Warnings Skin 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. If swallowed, get medical help or contact a Poison

Control Center right away.

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

Other information •protect the product in this container from excessive heat

and direct sun

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 1.19 g in 70 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 5.25 g in 70 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
GLYCERIN
MINERAL OIL
TITANIUM DIOXIDE
ALUMINUM OXIDE
DIMETHICONE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
MYRISTYL MYRISTATE
TROLAMINE
CETOSTEARYL ALCOHOL
STEARIC ACID
PALMITIC ACID
PEG-20 STEARATE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
MANNITOL
BETADEX
YEAST, UNSPECIFIED
SODIUM SUCCINATE ANHYDROUS
PANTHENOL
POLYACRYLAMIDE (1500 MW)
C13-14 ISOPARAFFIN
LAURETH-7
HONEY
MARINE COLLAGEN, SOLUBLE
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW)
SODIUM PYRROLIDONE CARBOXYLATE
SERINE
GLYCOGEN
BUTYLENE GLYCOL
CARBOXYPOLYMETHYLENE
POLYSORBATE 20
PALMITOYL TRIPEPTIDE-1
PALMITOYL TETRAPEPTIDE-7
.ALPHA.-TOCOPHEROL ACETATE
SODIUM POLYACRYLATE (2500000 MW)
POLYISOBUTYLENE (1000 MW)
ALLANTOIN
ROSA CANINA FRUIT OIL
SALICYLIC ACID
JASMINUM OFFICINALE FLOWER
SOY PROTEIN
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68975-200-70 1 JAR in 1 CARTON contains a JAR
1 70 g in 1 JAR This package is contained within the CARTON (68975-200-70)
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)

Revised: 11/2021 Emilia Resources, LLC

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