EGF UV SHIELD- octinoxate 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.

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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

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures(see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun.

Inactive ingredient

Water, Propylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Poly(C6-14 Olefin), Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Disteardimonium Hectorite, Magnesium Sulfate, Sorbitan Sesquioleate, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, Sorbitan Isostearate, Squalane, Simmondsia Chinensis(Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Chrysanthellum Indicum Extract, Chaenomeles Sinensis Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lecithin, Sorbitol, Xanthan Gum, Glyceryl Linoleate, Glyceryl Linolenate, rh-Oligopeptide-1, Acetyl Hexapeptide-8, Sodium Ascorbate, Retinyl Palmitate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Fragrance

EGF UV Shield

EGF UV Shield

Net WT. 2.03 fl. oz(60ml)

image of carton label

EGF UV SHIELD 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58831-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 60 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 60 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 60 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.15 g  in 60 g
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE2 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BETAINE (UNII: 3SCV180C9W)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PURSLANE (UNII: M6S840WXG5)  
PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SQUALANE (UNII: GW89575KF9)  
JOJOBA OIL (UNII: 724GKU717M)  
MACADAMIA OIL (UNII: 515610SU8C)  
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
CHAENOMELES SINENSIS FRUIT (UNII: 6S5Q1Q537Z)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
SODIUM ASCORBATE (UNII: S033EH8359)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
Product Characteristics
Colorwhite (silver) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58831-1001-21 in 1 BOX12/01/2018
1NDC:58831-1001-160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/26/2013
Labeler - Dermaesthetics Inc. (688384549)
Registrant - Dermaesthetics Inc. (688384549)
Establishment
NameAddressID/FEIBusiness Operations
Eyesome Co Ltd557795360manufacture(58831-1001)
Establishment
NameAddressID/FEIBusiness Operations
Dermaesthetics Inc.688384549relabel(58831-1001)

Revised: 12/2019
Document Id: 9a56a954-26b7-5bd9-e053-2a95a90a739b
Set id: 18a533a4-ca50-4f98-a04f-663861cc65bd
Version: 3
Effective Time: 20191222
 
Dermaesthetics Inc.