FDA.reportPublic FDA data

Avobenzone, Octinoxate, Octisalate, Oxybenzone

Manufacturer
Bath & Body Works, Inc. | Process Technologies & Packaging, LLC
Effective date
2013-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:56

Label at a glance#

ProductPatricia Wexler Universal Anti-Aging Moisturizer with Sunscreen Broad Spectrum SPF 28
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
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

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.8%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 2.4%

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

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 immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a 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 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
  • children under 6 months of age: ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua, Eau), Butylene Glycol, Isostearyl Neopentanoate, Cetearyl Alcohol, Myristyl Nicotinate, Glycerin, Cyclopentasiloxane, Hydrogenated Lecithin, Arctostaphylos Uva Ursi Leaf Extract, Betula Alba Bark Extract, Morus Alba Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cinnamomum Cassia Bark Extract, Glycine Soja (Soybean) Seed Extract, Rheum Palmatum Root/Stalk Extract, Sodium Hyaluronate, Arbutin, Dimethylcyclohexylethoxy Isobutylpropanoate, Phospholipids, Triacetin, N-Hydroxysuccinimide, Chrysin, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Dipotassium Glycyrrhizate, Trehalose, Xanthan Gum, Chlorphenesin, Isononyl Isononanoate, Pentaerythrityl Tetraethylhexanoate, Cetearyl Glucoside, Ascorbyl Glucoside, Tetrahexyldecyl Ascorbate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysilicone-11, Carbomer, Sucrose, Urea, Steareth-20, Sodium PCA, Cyclohexasiloxane, Polyquaternium-51, Disodium EDTA, Triethanolamine, Methyldihydrojasmonate, Cyclamen Aldehyde, Ethyl 2,2-Dimethylhydrocinnamal, Delphone, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Ethylparaben, Benzoic Acid, Isobutylparaben, Mica, Titanium Dioxide (CI 77891).

COMPANY INFORMATION

SPL UNCLASSIFIED SECTION

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1MM1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62670-8043-62019-11-27C16284748780-19855d018-de77-cd31-e053-dbdaa90ab51a1d8891aa-2e7f-41f8-a94e-d816809fd746

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62670-8043-6Patricia Wexler Universal Anti-Aging Moisturizer with Sunscreen Broad Spectrum SPF 2850 mL in 1 JARLOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62670-8043PATRICIA WEXLER UNIVERSAL ANTI-AGING MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 28 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BATH & BODY WORKS, INC.]1Legacy NDC, 1 package rows20130919_1d8891aa-2e7f-41f8-a94e-d816809fd746.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62670-804362670-8043-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT

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
14af5e69-d00b-411b-8274-df6eab3a49c31d8891aa-2e7f-41f8-a94e-d816809fd7462013-08-29WarningsExact identifier
spl id: 14af5e69-d00b-411b-8274-df6eab3a49c3
spl set id: 1d8891aa-2e7f-41f8-a94e-d816809fd746

Reported adverse events (FAERS/openFDA)#

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