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

Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Averr Aglow LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient[s]

Zinc Oxide 15%

Titanium Dioxide 2.4%

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.

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

• Shake well before use
• Apply liberally and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use 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:
  1. limiting time in the sun, especially from 10 a.m. - 2 p.m.
  2. wearing long-sleeve shirts, pants, hats, and sunglasses
  3. children under 6 months: Ask a doctor

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81664-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	166.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	26.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81664-001-01	1 in 1 CARTON	05/14/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/14/2021

Labeler - Averr Aglow LLC (959806535)