FDA.reportPublic FDA data

The Better Oil

Manufacturer
frank body
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:41:40

Label at a glance#

ProductThe Better Oil
Active ingredientAVOBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure9 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 generously and evenly 15 minutes before sun exposure•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: L...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octocrylene 8%

Avobenzone 3%

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: Do not use near heat, flame, or while smoking

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously and evenly 15 minutes before sun exposure•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 10a.m.-2p.m.
  • Wear long sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Paraffinum Liquidum, Isopropyl Palmitate, Isostearyl Neopentanoate, Cocos Nucifera Oil, Silica, Prunus Amydalus Dulcis Oil, Simmondsia Chinensis Seed Oil, Theobroma Cacao Seed butter, Parfum, Tocopheryl Acetate, BHT, Mica CI 77492, Titanium Dioxide, CI 77491, CI 77499, Tin Oxide

Other information

SPL UNCLASSIFIED SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Contact us at frankbody.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frank body

SPF 30

THE BETTER OIL

UVA + UVB Broad Spectrum SPF 30

Sunscreen oil with golden shimmer

3.38 fl oz - 100 ml

Distributed by frank body: 33 Cremorne Street

Cremorne VIC 3121 Australia / frank body LLC:

1145 Broadway, Floor 4 New York, NY 10001, USA

Made in Australia

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82975-102-022025-02-01C16284748780-12cef2736-6198-d83d-e063-dadaa90ab31fThe Better Oil
82975-102-022025-01-30C16284748780-12cef2736-6198-d83d-e063-dadaa90ab31fThe Better Oil

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82975-102THE BETTER OIL (HOMOSALATE, OCTOCRYLENE, AVOBENZONE) OIL [FRANK BODY]3Legacy NDC20250201_e8bdbbfb-10df-8b5a-e053-2995a90a379b.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82975-10282975-102-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
STANNIC OXIDEKM7N50LOS6IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MINERAL OILT5L8T28FGPIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
ALMOND OIL66YXD4DKO9IACT
MICAV8A1AW0880IACT
COCOA BUTTER512OYT1CRRIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
COCONUT OILQ9L0O73W7LIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
JOJOBA BUTTERXIA46H803RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB

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
2cf8f155-0a7f-114b-e063-6394a90a75aee8bdbbfb-10df-8b5a-e053-2995a90a379b2025-01-30WarningsExact identifier
spl id: 2cf8f155-0a7f-114b-e063-6394a90a75ae
spl set id: e8bdbbfb-10df-8b5a-e053-2995a90a379b

Reported adverse events (FAERS/openFDA)#

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