AVA ISA PURE UNTINTED SPF 45- zinc oxide lotion 
Cyberderm Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AVA ISA Pure Untinted Ultra Matte Sunscreen SPF 45

Drug Facts

Active ingredient

Zinc oxide* 15%

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

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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
  • Children under 6 months of age: ask a doctor

Other information

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Inactive ingredients water/eau, coco-caprylate/caprate*, polyglyceryl-3 polyricinoleate*, isostearic acid*, polylactic acid*, caprylic/capric triglyceride*, propanediol*, undecane*, tridecane*, cetearyl olivate*, sorbitan olivate*, titanium dioxide, stearic acid, alumina, cerium dioxide, silica, aluminum hydroxide, polyhydroxystearic acid, caprylhydroxamic acid, caprylyl glycol, glycerin*, polygonum aviculare extract, xanthan gum.

Questions or comments?

781-481-2628 Monday - Friday 9 am - 5 pm

*Denotes ingredients that are Ecocert® certified organic.

Distributed by:

Cyberderm Laboratories Inc.

650-1600 Carling Avenue

Ottawa, ON K1Z 1G3 Canada

Made in Canada

AVA ISA

Pure Untinted Ultra Matte SPF 45 Sunscreen

with Certified Organic Bio UVA Ultra

Made with 15% Zinc Oxide

Transparent Sunscreen Lotion

UVA/UVB Broad Spectrum SPF 45

Helps Prevent Sunburn

50 mL (1.7 fl oz)

Ava Isa Untinted 50 mL

AVA ISA  PURE UNTINTED SPF 45
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71644-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOSTEARIC ACID (UNII: X33R8U0062)  
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
POLYLACTIDE (UNII: 459TN2L5F5)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPANEDIOL (UNII: 5965N8W85T)  
UNDECANE (UNII: JV0QT00NUE)  
TRIDECANE (UNII: A3LZF0L939)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
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)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71644-002-501 in 1 CARTON03/30/201805/31/2021
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:71644-002-801 in 1 CARTON03/30/201805/24/2021
280 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/30/201805/31/2021
Labeler - Cyberderm Laboratories Inc. (242524267)

Revised: 11/2020
Document Id: b48e526c-8dab-5e75-e053-2a95a90a7b79
Set id: 6908deb7-ff81-57cd-e053-2991aa0a9a75
Version: 2
Effective Time: 20201120
 
Cyberderm Laboratories Inc.