FDA.reportPublic FDA data

Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30

Manufacturer
Averr Aglow LLC
Effective date
2021-03-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:20

Label at a glance#

ProductAverr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure13 sections

Indications and 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

Dosage and administration

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: limiting ...

Label contents#

Full prescribing information#

Active Ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Titanium Dioxide 2.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

OTC - WHEN USING SECTION

  • 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 SECTION

For external use only.

Warnings

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

Warnings

OTC - WHEN USING SECTION

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

Warnings

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81664-001-012023-01-30C16284748780-1f386c64a-4062-0266-e053-dadaa90a7c1abcb982ed-1d5a-2aa1-e053-2995a90ad018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81664-001-01Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 3050 mL in 1 TUBELOTION502
81664-001-01Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81664-001AVERR AGLOW PURE PROTECTION INVISIBLE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [AVERR AGLOW LLC]2Legacy NDC, 2 package rows20210514_bcb982ed-1d5a-2aa1-e053-2995a90ad018.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81664-00181664-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDESU72Q2I8C85IACT
ISOSTEARIC ACIDX33R8U0062IACT
STEARIC ACID4ELV7Z65APIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
TOCOPHEROLR0ZB2556P8IACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ASTROCARYUM VULGARE KERNEL OIL1IQY04O559IACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
WATER059QF0KO0RIACT
PENTYLENE GLYCOL50C1307PZGIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
CARYODENDRON ORINOCENSE WHOLEJ2T2D81BHUIACT
GLYCERINPDC6A3C0OXIACT
TREMELLA FUCIFORMIS WHOLE4938BNS0GUIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
HIPPOPHAE RHAMNOIDES WHOLEYAA7TG74X6IACT
GRAPE SEED OIL930MLC8XGGIACT
RASPBERRY SEED OIL9S8867952AIACT
PHENYLPROPANOL0F897O3O4MIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
be23fb9c-08d8-056e-e053-2a95a90a4c02bcb982ed-1d5a-2aa1-e053-2995a90ad0182021-03-22WarningsExact identifier
spl id: be23fb9c-08d8-056e-e053-2a95a90a4c02
spl set id: bcb982ed-1d5a-2aa1-e053-2995a90ad018

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.