ZELENS DAILY DEFENCE MINERAL SUNSCREEN SPF 30- zinc oxide cream

Zelens Daily Defence Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

Zelens Daily Defence Mineral Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Zelens Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc Oxide 20%

Purpose

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

Wen 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 at least every 2 hours
• use a water resistant sunscreen if swimming or sweating

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 611 Pompton Plains, NJ 07444

Inactive ingredients

Aqua (Water), Caprylic/Capric Triglyceride, Propylheptyl Caprylate, Glycerin, Butyloctyl Salicylate, Lauryl Lactate, Propanediol, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Alpha-glucan Oligosaccharide, Lactobacillus, Lecithin, Dimethicone, Acetyl Hexapeptide-1 Perilla Frutescens Leaf Extract, Camellia Sinensis Leaf Extract, Centella Asiatica Leaf Extract, Malpighia Glabra (Acerola) Fruit Extract, Ginkgo Biloba Leaf Extract, Punica Granatum Fruit Extract, Haematococcus Pluvialis Extract, Pongamia Pinnata Seed Extract, Dunliella Salina Extract, Pongamia Glabra Seed Oil, Diisopropyl Sebacate, Benzyl Alcohol, Isopropyl Palmitate, Xanthan Gum, Propylene Glycol Dicaprylate/dicaprate, Tocopherol, Sodium Stearoyl Glutamate, C12-15 Alkyl Benzoate, Diisopropyl Adipate, Dehydroacetic Acid, Sodium Dehydroacetate, Polymnia Sonchifolia Root Juice, Maltodextrin, Sorbitol, Citric Acid, Sodium Benzoate, Potassium Sorbate.

Company Information

ZELENS LIMITED

LONDON SW1V 3JL, UK

www.zelens.com

Product Packaging

INGREDIENTS AND APPEARANCE

ZELENS DAILY DEFENCE MINERAL SUNSCREEN SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63712-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
LAURYL LACTATE (UNII: G5SU0BFK7O)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)
POMEGRANATE (UNII: 56687D1Z4D)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
GINKGO (UNII: 19FUJ2C58T)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITOL (UNII: 506T60A25R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
WATER (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
KARUM SEED OIL (UNII: 62160PU6FJ)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SMALLANTHUS SONCHIFOLIUS ROOT JUICE (UNII: M9S7HX36CT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63712-001-01	1 in 1 CARTON	04/01/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63712-001-02	2 mL in 1 PACKET; Type 0: Not a Combination Product	05/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	04/01/2023

Labeler - Zelens Limited (217149018)