FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate, Octocrylene

Manufacturer
Avert Skincare Inc | Inspec solutions LLC
Effective date
2022-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:06:07

Label at a glance#

ProductAvobenzone, Homosalate, Octisalate, Octocrylene
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure14 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure children under 6 months: ask a doctor Hold container 6 to 8 inches from the skin to apply reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours ​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 Spect...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • children under 6 months: ask a doctor
  • Hold container 6 to 8 inches from the skin to apply
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • ​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

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product from excessive heat and direct sun
  • May Stain Fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

disclaimer

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

Oxybenzone & Octinoxate free

Reef Safe

Non- Comedogenic

Adverse Reactions

ADVERSE REACTIONS SECTION

Questions? 1-800-661-5804

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelUnscented Sunscreen

SPF 50

water resistant 80 minutes

Facemist

BROAD

SPECTRUM

SPF 50

3.38 FL OZ (100 ML)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82603-000-012025-12-09C16284748780-11030e365-56d4-111a-e063-dadaa90a10e2Avert Facemist SPF50
82603-000-012024-01-30C16284748780-11030e365-56d4-111a-e063-dadaa90a10e2Avert Facemist SPF50

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82603-000AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY [AVERT SKINCARE INC]1Legacy NDC20220316_da48b689-c929-27fe-e053-2a95a90a8d51.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82603-00082603-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYL PALMITATE2865993309IACT
STEAROXYTRIMETHYLSILANE9862TW94B2IACT
OCTOCRYLENE5A68WGF6WMACTIB
TOCOPHEROLR0ZB2556P8IACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
ALCOHOL3K9958V90MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
GLYCERINPDC6A3C0OXIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
458ae1f2-7e39-b4f5-e063-6394a90a5573da48b689-c929-27fe-e053-2a95a90a8d512025-12-09Warnings, Adverse reactionsExact identifier
spl set id: da48b689-c929-27fe-e053-2a95a90a8d51

Reported adverse events (FAERS/openFDA)#

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