FDA.reportPublic FDA data

Hydrating Body Sunscreen UVA and UVB Broad Spectrum SPF50

Manufacturer
Baxter Laboratories Pty. Ltd.
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:35

Label at a glance#

ProductHydrating Body Sunscreen UVA and UVB Broad Spectrum SPF50
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Homosalate 10% .............Sunscreen

Octocrylene 8% ...............Sunscreen

Octisalate 5% ..................Sunscreen

Avobenzone 3% ..............Sunscreen

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep our of reach of children.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

  • 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.
  • If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 INGREDIENT SECTION

Inactive ingredients

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

OTHER SAFETY INFORMATION

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

Questions or comments?
Contact us at frankbody.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frank body

SPF 50+

Hydrating Body Sunscreen

UVA + UVB Broad Spectrum SPF50+

With hyaluronic acid

Fast absorbing

Water resistant (80 minutes)

4.73fl oz - 140ml

SPF 50 hydrating labelSPF 50 hydrating label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70157-009HYDRATING BODY SUNSCREEN UVA AND UVB BROAD SPECTRUM SPF50 (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [BAXTER LABORATORIES PTY. LTD.]2Legacy NDC20241020_eea4461d-3ccb-a410-e053-2995a90a5558.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
70157-00970157-009-01

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
CYCLOMETHICONE 6XHK3U310BAIACT
HYALURONATE SODIUMYSE9PPT4THIACT
MALTODEXTRIN7CVR7L4A2DIACT
KAKADU PLUM0ZQ1D2FDLIIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
HOMOSALATEV06SV4M95SACTIB
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
BENZYL ALCOHOLLKG8494WBHIACT
TROLAMINE9O3K93S3TKIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
YELLOW WAX2ZA36H0S2VIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
JOJOBA OIL724GKU717MIACT
RASPBERRY SEED OIL9S8867952AIACT
OCTISALATE4X49Y0596WACTIB
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT

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
427a5c4c-faf6-78e8-e063-6294a90abecdeea4461d-3ccb-a410-e053-2995a90a55582025-10-31WarningsExact identifier
spl set id: eea4461d-3ccb-a410-e053-2995a90a5558

Reported adverse events (FAERS/openFDA)#

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