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

BODY DEFENCE SUNSCREEN Broad Spectrum SPF30 by

Drug Labeling and Warnings

BODY DEFENCE SUNSCREEN Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by ZELENS Limited, Originitalia. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

• 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.

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.

INGREDIENTS AND APPEARANCE

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63712-201-01	1 in 1 BOX	05/01/2016
1		125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2016

Labeler - ZELENS Limited (217149018)

Establishment
Name	Address	ID/FEI	Business Operations
Originitalia		441072253	manufacture(63712-201)