FDA.reportPublic FDA data

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone

Manufacturer
Bath & Body Works, Inc. | 220 Labs Inc.
Effective date
2013-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:03

Label at a glance#

ProductTrue Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 minutes) Monoi Oil
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure14 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

Spray liberally and spread evenly by hand 15 minutes before sun exposure.  Hold container 4 to 6 inches from skin to apply.  Do not spray directly into face.  Spray on hands then apply to face.  Do not apply in windy conditions.  Use in a well ventilated area. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun in...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, Oxybenzone 6.0%

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.

FLAMMABLE

WARNINGS SECTION

Keep away from flame or high heat.

  • Contents under pressure.  Do not puncture or incinerate.  Do not store at temperatures above 120°F (50°C).

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.
  • keep away from face to avoid breathing in
  • use only as directed.  Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.  Hold container 4 to 6 inches from skin to apply.  Do not spray directly into face.  Spray on hands then apply to face.  Do not apply in windy conditions.  Use in a well ventilated area.
  • Reapply:
  • after 40 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
  • 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

Isobutane, Alcohol Denat., Polyester-8, Acrylates/Octylacrylamide Copolymer, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Tocopheryl Acetate, Fragrance (Parfum), Dimethicone, Ethoxydiglycol, Butylene Glycol, Trisiloxane, Polyester-10, Propylene Glycol Dibenzoate.

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
62670-8046-02019-11-27C16284748780-19855d018-d4ff-cd31-e053-dbdaa90ab51a33babd07-3bbb-4d22-8008-bcb47e3c9d94

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62670-8046-0True Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 minutes) Monoi Oil113 g in 1 CANAEROSOL, SPRAY1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62670-8046TRUE BLUE SPA COOLING SUNSCREEN MIST BROAD SPECTRUM SPF 25 WATER RESISTANT (40 MINUTES) MONOI OIL (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [BATH & BODY WORKS, INC.]1Legacy NDC, 1 package rows20130930_33babd07-3bbb-4d22-8008-bcb47e3c9d94.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62670-804662670-8046-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
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
90ac3b6a-ce75-4a98-9d31-7a706b7572ad33babd07-3bbb-4d22-8008-bcb47e3c9d942013-09-30WarningsExact identifier
spl id: 90ac3b6a-ce75-4a98-9d31-7a706b7572ad
spl set id: 33babd07-3bbb-4d22-8008-bcb47e3c9d94

Reported adverse events (FAERS/openFDA)#

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