AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE- avobenzone, homosalate, octisalate, octocrylene spray 
Avert Skincare 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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Avert Facemist SPF50

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other Information

Inactive ingredients

Acrylates/octylacrylamide copolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, Tocopherol, caprylic/capric triglyceride, diethylhexyl syringylidene malonate, glycerin, Retinyl palmitate, stearoxytrimethylsilane

disclaimer

May stain or damage some fabrics or surfaces

Oxybenzone & Octinoxate free

Reef Safe

Non- Comedogenic

Adverse Reactions

Questions? 1-800-661-5804

principal display panel

LabelUnscented Sunscreen

SPF 50

water resistant 80 minutes

Facemist

BROAD

SPECTRUM

SPF 50

3.38 FL OZ (100 ML)

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82603-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
ALCOHOL (UNII: 3K9958V90M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
GLYCERIN (UNII: PDC6A3C0OX)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82603-000-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/15/2022
Labeler - Avert Skincare Inc (243258452)
Registrant - Avert Skincare Inc (243258452)
Establishment
NameAddressID/FEIBusiness Operations
Inspec solutions LLC081030372manufacture(82603-000)

Revised: 3/2022
Document Id: da48b689-c92a-27fe-e053-2a95a90a8d51
Set id: da48b689-c929-27fe-e053-2a95a90a8d51
Version: 1
Effective Time: 20220315
 
Avert Skincare Inc