BODY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30- octinoxate, octisalate, homosalate, avobenzone, and octocrylene oil 
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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BODY DEFENCE SUNSCREEN Broad Spectrum SPF30

Drug Facts

Active ingredientsPurpose
Avobenzone 3.0%Sunscreen
Homosalate 5.0%Sunscreen
Octinoxate 7.5%Sunscreen
Octisalate 5.0%Sunscreen
Octocrylene 2.75%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

Caprylic/Capric Triglyceride, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Dicaprylyl Ether, Olea Europaea (Olive) Fruit Oil, Sesamum Indicum (Sesame) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Polyester-7, Phospholipids, Perilla Frutescens Leaf Extract, Astragalus Membranaceus Root Extract, Curcuma Longa (Turmeric) Root Extract, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Emblica Officinalis Fruit Extract, Echinacea Angustifolia Leaf Extract, Polypodium Leucotomos Root Extract, Rhodiola Rosea Root Extract, Silybum Marianum Extract, Ginkgo Biloba Leaf Extract, Pinus Strobus Bark Extract, Daucus Carota Sativa (Carrot) Root Extract, Glycine Soja (Soybean) Sterols, Glycolipids, Glycine Soja (Soybean) Oil, Zingiber Officinale Root Oil, Citrus Bergamia Melarosa Peel Oil Expressed, Citrus Limon Peel Oil, Citrus Aurantium Leaf Oil, Citrus Aurantifolia Peel Oil Distilled, Juniperus Mexicana Wood Oil, Coriandrum Sativum Seed Oil, Elettaria Cardamomum Seed Oil, Ferula Kokanica Resin Oil, Litsea Cubeba Fruit Oil, Myristica Fragrans Fruit Oil (Nutmeg), Salvia Sclarea Flower Oil, Thymus Vulgaris Oil, Tocopherol.

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Box

zelens
dr marko lens

Body Defence

SUNSCREEN
BROAD SPECTRUM SPF 30

Water Resistant (40 minutes)

Silky Oil

125 mL / 4.2 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Box
BODY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30 
octinoxate, octisalate, homosalate, avobenzone, and octocrylene oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63712-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SESAME OIL (UNII: QX10HYY4QV)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
POLYESTER-7 (UNII: 0841698D2F)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)  
TURMERIC (UNII: 856YO1Z64F)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
GINKGO (UNII: 19FUJ2C58T)  
PINUS STROBUS BARK (UNII: 8PJ4761097)  
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
PHLEBODIUM AUREUM ROOT (UNII: VPS45WBU8U)  
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)  
MILK THISTLE (UNII: U946SH95EE)  
CARROT (UNII: L56Z1JK48B)  
SOY STEROL (UNII: PL360EPO9J)  
SOYBEAN OIL (UNII: 241ATL177A)  
GINGER (UNII: C5529G5JPQ)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
LEMON OIL (UNII: I9GRO824LL)  
BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
LIME OIL (UNII: UZH29XGA8G)  
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
CORIANDER OIL (UNII: 7626GC95E5)  
CARDAMOM OIL (UNII: JM0KJ091HZ)  
GALBANUM OIL (UNII: 211UF7M8N1)  
LITSEA OIL (UNII: 2XIW34BN6O)  
NUTMEG OIL (UNII: Z1CLM48948)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
THYME OIL (UNII: 2UK410MY6B)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63712-201-011 in 1 BOX05/01/2016
1125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2016
Labeler - ZELENS Limited (217149018)
Establishment
NameAddressID/FEIBusiness Operations
Originitalia441072253manufacture(63712-201)

Revised: 11/2019
Document Id: 96a4f339-5504-3dda-e053-2a95a90aed03
Set id: 75d985ca-971d-4529-a9f0-685c8879b942
Version: 2
Effective Time: 20191105
 
ZELENS Limited