FDA.reportPublic FDA data

Hydrating Body Sunscreen

Manufacturer
frank body
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:41:40

Label at a glance#

ProductHydrating Body Sunscreen
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
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 swweating.• Immediately after towel drying.• At leaset 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 includin...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octocrylene 8%

Octisalate 5%

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

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 contat 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 swweating.• Immediately after towel drying.• At leaset 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

Water, Beeswax, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Simmondsia Chinesis Seed Oil, Rubus Idaeus Seed Oil, Tocopheryl Acetate, Sodium Hyaluronate, Parfum, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Citric acid

Other informaiton

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 50+

HYDRATING BODY SUNSCREEN

UVA + UVB Broad Spectrum SPF 50+

With hyaluronic acid

Fast absorbing

Water resistant (80 minutes)

4.73 fl oz - 140 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
82975-101-012025-02-01C16284748780-12cef2736-ace4-d83d-e063-dadaa90ab31fHydrating Body Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82975-101HYDRATING BODY SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [FRANK BODY]2Legacy NDC20250201_e8bb47dd-7d80-1647-e053-2995a90ac881.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82975-10182975-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
CYCLOMETHICONE 50THT5PCI0RIACT
KAKADU PLUM0ZQ1D2FDLIIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
JOJOBA OIL724GKU717MIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
BENZYL ALCOHOLLKG8494WBHIACT
MALTODEXTRIN7CVR7L4A2DIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB

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
2cf8c696-00f9-e56c-e063-6394a90a78ffe8bb47dd-7d80-1647-e053-2995a90ac8812025-01-30WarningsExact identifier
spl id: 2cf8c696-00f9-e56c-e063-6394a90a78ff
spl set id: e8bb47dd-7d80-1647-e053-2995a90ac881

Reported adverse events (FAERS/openFDA)#

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