AVERR AGLOW PURE PROTECTION INVISIBLE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide and titanium dioxide lotion 
Averr Aglow LLC

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.

----------

Active Ingredient[s]

Zinc Oxide 15%

Titanium Dioxide 2.4%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Warnings

Do not use on damaged or broken skin

Warnings

When using this product keep out of eyes. Rinse with water to remove

Warnings

Stop use and ask a doctor if rash occurs

Warnings

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

Directions

Inactive Ingredients

Deionized Water (Aqua), Caprylic/Capric Triglyceride (RSPO Palm Kernel Derived), Polyglyceryl-6 Stearate (Vegetable Derived), Glycerin (Organic), Corn Starch Modified (non-GMO), Methylpropanediol, Caryodendron Orinocense (Kahai) Seed Oil, Shea Butter Ethyl Esters, Tocopherol (Vitamin E), Niacinamide, Sodium Hyaluronate, Astrocaryum (Tucuma) Seed Butter, Tremella Fuciformis Polysaccharide, Bisabolol, Hippophae Rhamnoides (Sea Buckthorn) Oil, Punica Granatum (Pomegranate) Seed Oil, Pentylene Glycol (Vegetable Derived), Polyhydroxystearic Acid, Polyglyceryl-6 Behenate (Vegetable Derived), Alumina, Rubus Idaeus (Raspberry) Seed Oil, Stearic Acid, Vitis Vinifera (Grape) Seed Oil, Isostearic Acid, Polyglyceryl-3 Polyricinoleate (Vegetable Derived), Caprylyl Glycol, Lecithin, Phenylpropanol, Hydroxyethylcellulose

Other Information

Protect this product from excessive heat and direct sun. Report serious adverse effects to: (855) 918-3206 (US)

Questions or Comments?

Call toll free: (855) 918-3206 (US)

Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30

Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30

AVERR AGLOW PURE PROTECTION INVISIBLE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81664-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE166.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE26.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NIACINAMIDE (UNII: 25X51I8RD4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559)  
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
CARYODENDRON ORINOCENSE WHOLE (UNII: J2T2D81BHU)  
GLYCERIN (UNII: PDC6A3C0OX)  
TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
HIPPOPHAE RHAMNOIDES WHOLE (UNII: YAA7TG74X6)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81664-001-011 in 1 CARTON05/14/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/14/2021
Labeler - Averr Aglow LLC (959806535)

Revised: 3/2021
Document Id: be23fb9c-08d8-056e-e053-2a95a90a4c02
Set id: bcb982ed-1d5a-2aa1-e053-2995a90ad018
Version: 2
Effective Time: 20210322
 
Averr Aglow LLC