DAILY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30- octinoxate, octisalate, avobenzone, and octocrylene cream 
ZELENS Limited

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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DAILY DEFENCE SUNSCREEN Broad Spectrum SPF30

Drug Facts

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Octionoxate 7.4%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 2.7%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water, Cyclohexasiloxane, Glycerin, Butylene Glycol, Butyloctyl Salicylate, Isononyl Isononanoate, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Micrococcus Lysate, Perilla Frutescens Leaf Extract, Sodium Hylauronate, Glutamylamidoethyl Imidazole, Ascorbyl Tetraisopalmitate, Tocopheryl Acetate, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Echinacea Angustifolia Leaf Extract, Ginkgo Biloba Leaf Extract, Pinus Strobus Bark Extract, Lecithin, Silica, Hydrogenated Palm Glycerides, Cyclopentasiloxane, PVP, Potassium Cetyl Phosphate, Sorbitol, Ceteareth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Fragrance, Linalool, Sorbic Acid, Chlorphenesin, Phenoxyethanol, BHT, Sodium Hydroxide, Disodium EDTA

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

zelens
dr marko lens

Daily Defence

SUNSCREEN
BROAD SPECTRUM SPF 30

High Protection

50 mL / 1.7 Fl.Oz.

Principal Display Panel - 50 mL Tube Box
DAILY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30 
octinoxate, octisalate, avobenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63712-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
GINKGO (UNII: 19FUJ2C58T)  
PINUS STROBUS BARK (UNII: 8PJ4761097)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SORBITOL (UNII: 506T60A25R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SORBIC ACID (UNII: X045WJ989B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63712-123-011 in 1 BOX06/02/2014
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/02/2014
Labeler - ZELENS Limited (217149018)
Establishment
NameAddressID/FEIBusiness Operations
Originitalia441072253manufacture(63712-123)

Revised: 11/2019
Document Id: 96b1f165-c9e7-bfae-e053-2a95a90a05ca
Set id: 373d835c-762a-485b-8489-8a596234fb7b
Version: 2
Effective Time: 20191106
 
ZELENS Limited