CYBERDERM SIMPLY ZINC LITE- zinc oxide lotion

Cyberderm Simply Zinc Lite by

Drug Labeling and Warnings

Cyberderm Simply Zinc Lite by is a Otc medication manufactured, distributed, or labeled by Cyberderm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc oxide* 25%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

Warnings

For external use only

DO NOT USE

Do not use on broken skin

WHEN USING

When using this product avoid contact eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

Adults and children over 6 months of age

• Apply liberally to face and body 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 value 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-sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING

Other information

• Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Non-medicinal ingredients caprylic/capric triglyceride*, coco-caprylate/caprate*, polyglyceryl-3 polyricinoleate*, isostearic acid*, polylactic acid*, coconut alkanes*, sodium-phospho-magnesium silicate, carthamus tinctorius oleosomes*, water/eau, picea abies extract, propanediol*, titanium dioxide, stearic acid, alumina, cerium dioxide, silica, aluminum hydroxide, polyhydroxystearic acid.

QUESTIONS

Questions?

718-481-2628 Monday - Friday 9 am - 5 pm

SPL UNCLASSIFIED SECTION

Distributed by:

Cyberderm Laboratories Incorporated

650-1600 Carling Avenue

Ottawa, ON K1Z 1G3 Canada

Made in Canada

www.thesunscreencompany.com

PRINCIPAL DISPLAY PANEL

cyberderm

made with love by the sunscreen company™

Simply Zinc Lite

Transparent sunscreen lotion

made with 25% zinc oxide with Certified Organic Bio UVA

Ultra and Sheer Illuminating Tint

UVA/UVB Broad Spectrum SPF 50

helps prevent sunburn

100 mL (3.4 fl oz)

INGREDIENTS AND APPEARANCE

CYBERDERM SIMPLY ZINC LITE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
PICEA ABIES FLOWER BUD (UNII: WQZ50FAU2B)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CERIC OXIDE (UNII: 619G5K328Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCONUT ALKANES (UNII: 1E5KJY107T)
ISOSTEARIC ACID (UNII: X33R8U0062)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYLACTIDE (UNII: 459TN2L5F5)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-008-01	1 in 1 CARTON	06/18/2020
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/18/2020

Labeler - Cyberderm Laboratories Inc. (242524267)