Body defence sunscreen broad spectrum spf30 oil

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

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

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

Warnings

For external use only

Otc - do not use section

Do not useon damaged or broken skin

Otc - when using section

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

Otc - stop use section

Stop use and ask a doctorif rash occurs

Otc - keep out of reach of children section

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

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    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

Other information

  • protect this product from excessive heat and direct sun
  • you may report a serious adverse reaction to this product to: Report Reaction, LLC
    PO Box 22 Plainsboro, NJ 08536-0222

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.

Ingredients and appearance - Product information

Body defence sunscreen broad spectrum spf30 oil- Octinoxate, octisalate, homosalate, avobenzone, and octocrylene

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63712-201
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 75 mgin 1 mL
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 50 mgin 1 mL
Homosalate ( UNII: V06SV4M95S)( Homosalate - UNII: V06SV4M95S ) 50 mgin 1 mL
Avobenzone ( UNII: G63QQF2NOX)( Avobenzone - UNII: G63QQF2NOX ) 30 mgin 1 mL
Octocrylene ( UNII: 5A68WGF6WM)( Octocrylene - UNII: 5A68WGF6WM ) 27.5 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
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 top ( 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

Color YELLOW

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part352 USA

Labeler - ZELENS Limited( 217149018)

Establishment

Name ID/FEI Business Operations
ZELENS Limited 217149018 MANUFACTURE( 63712-201)

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.