EGF UV SHIELD- oxtinoxate cream 
Dermaesthetics 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.

----------

EGF UV Shield

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

label

EGF UV SHIELD 
oxtinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58831-2001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.15 g  in 100 mL
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58831-2001-160 mL in 1 TUBE; Type 0: Not a Combination Product07/07/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/07/2018
Labeler - Dermaesthetics Inc. (688384549)
Registrant - Dermaesthetics Inc. (688384549)
Establishment
NameAddressID/FEIBusiness Operations
Eyesome Co Ltd557795360manufacture(58831-2001)
Establishment
NameAddressID/FEIBusiness Operations
Dermaesthetics Inc.688384549relabel(58831-2001)

Revised: 12/2019
Document Id: 9a585410-428a-2eb0-e053-2a95a90af244
Set id: 705f9494-f60b-f5fb-e053-2991aa0adda4
Version: 2
Effective Time: 20191222
 
Dermaesthetics Inc.