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

DAILY DEFENCE SUNSCREEN Broad Spectrum SPF30 by

Drug Labeling and Warnings

DAILY 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%	Sunscreen
Octionoxate 7.4%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 2.7%	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

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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63712-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	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 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63712-123-01	1 in 1 BOX	06/02/2014
1		50 mL in 1 TUBE; 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	06/02/2014

Labeler - ZELENS Limited (217149018)

Establishment
Name	Address	ID/FEI	Business Operations
Originitalia		441072253	manufacture(63712-123)