EGF UV SHIELD- oxtinoxate cream

EGF UV SHIELD by

Drug Labeling and Warnings

EGF UV SHIELD by is a Otc medication manufactured, distributed, or labeled by Dermaesthetics Inc., Eyesome Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fact

Active ingredient
Octinoxate 7.50%
Octisalate 5.00%
Zinc Oxide 4.90%
Titanium Dioxide 4.15%
Amiloxate 2.00%

Purpose

Sunscreen

Keep out of reach of children

Stop use and ask a doctor

if rash or irritation develops and lasts.

Keep out of reach of children

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

Indication & usage

Directions
-Apply generously and evenly 15-20 minutes before sun exposure.

-Use a water resistant sunscreen if swimming or sweating.

-Reapply every 1-2 hours after towel drying, swimming or perspiring.

-Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures

including:

- limit time in the sun, especially from 10 a.m. ~ 2 p.m.

- wear long-sleeve shirts, pants, hats, and sunglasses

-Children under 6 months: Ask a doctor

Warning

Warnings

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin. If sun irritation develops or increases.

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

Dosage & administration

for external use only

Inactive ingredient

Water, Propylene Glycol, Cyclopentasiloxane, Hydrogenated Poly(C6-14 Olefin Polymer), pentylent glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, butylene glycol, Aluminum Hydroxide, Stearic Acid, silica Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate Crosspolymer, caprylyl glycol, tocopheryl acetate, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, jojoba seed oil, ethyhexylglycerin, Aloe Barbadensis Leaf Juice, squalane, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, macadamia ternifolia seed oil, rh-oligopeptide-1, chaenomeles sinensis fruit extract, cinnamomum cassia bark extract, diospyros kaki leaf extract, artemisia princeps leaf extract, sorbitol, camellia sinensis leaf extract, glycerin, chrysanthellum indicum extract, lecithin, glyceryl linoleate, glyceryl linolenate, phenoxyethano, xanthan gum, acetyl hexapeptide-8, sodium ascorbyl phosphate, retinyl palmitate, di-sodium edta, glyceryl caprylate, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EGF UV SHIELD 
oxtinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58831-2001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.15 g  in 100 mL
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8)	AMILOXATE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58831-2001-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/07/2018

Labeler - Dermaesthetics Inc. (688384549)

Registrant - Dermaesthetics Inc. (688384549)

Establishment
Name	Address	ID/FEI	Business Operations
Eyesome Co Ltd		557795360	manufacture(58831-2001)

Establishment
Name	Address	ID/FEI	Business Operations
Dermaesthetics Inc.		688384549	relabel(58831-2001)