FDA.reportPublic FDA data

Unscented Classic Face

Manufacturer
Bell International Laboratories
Effective date
2017-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:14:13

Label at a glance#

ProductUnscented Classic Face SPF 30 Broad Spectrum
Active ingredientOCTINOXATE, AVOBENZONE
Label structure8 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

apply liberally 15 minutes before sun exposure reapply: 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 the risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protectin measures including: limit time in the sun, especially from 10am-2pm wear long-sleeve s...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%, Octinoxate 2.1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE 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

Do not use on damaged or broken skin

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

Stop use and ask doctor if skin rash occurs

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

apply liberally 15 minutes before sun exposure

reapply:

  • 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 the risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protectin measures including:

  • limit time in the sun, especially from 10am-2pm
  • wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylohydroxamic Acid

Caprylyl Glycol

Carthamus Tinctorius (Safflower) Oleosomes

Citrus Aurantium Dulcis (Orange) Fruit Water

Dicaprylyl Carbonate

Euterpe Oleracea (Acai) Fruit Oil

Fragaria Vesca (Strawberry) Fruit Extract

Glycerin

Helianthus Annuus (Sunflower) Seed Extract

Hydrogenated Polydecene

Linum Usitatissimum (Linseed) Seed Oil

Oenothera Biennis (Evening Primrose) Oil

Plankton Extract

Propanediol

Sodium Polyacryloyldimethyl Taurate

Sodium Stearoyl Glutamate

Trideceth-10

Trisodium Ethylenediamine Disuccinate

Water

Xanthan Gum

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

tube artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tubetube

display box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

display boxdisplay box

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76150-11476150-114-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
ORANGE5EVU04N5QUIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER SEEDR9N3379M4ZIACT
ALPINE STRAWBERRYCG6IX3GCMUIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ACAI OILZ0W6766A2WIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
LINSEED OIL84XB4DV00WIACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
TRIDECETH-10G624N6MSBAIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
XANTHAN GUMTTV12P4NEEIACT

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
b8de074d-1919-1de7-e053-2a95a90aa37055f2e487-0e3b-15b1-e054-00144ff8d46c2021-01-14WarningsExact identifier
spl set id: 55f2e487-0e3b-15b1-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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