FDA.reportPublic FDA data

Tan De Soleil Orange Tanning Balm SPF 6

Manufacturer
TANNING CLUB, LLC
Effective date
2024-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:27

Label at a glance#

ProductTan De Soleil Orange Tanning Balm SPF 6
Active ingredientHOMOSALATE, OCTISALATE
Label structure8 sections

Indications and uses

Helps prevent sunburn. higher SPF gives more sunburn protection 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 and as needed. Children under 6 months of age: ask a doctor. 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protectio...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Homosalate 3.00%

Octisalate 4.0%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • 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 or irritation develops and lasts.

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 right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF 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.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Iron Oxide (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Theobroma Cacao (Cocoa) Butter), I-Tyrosine, Tocopheryl Acetate (Vitamin E), D&C Red#17.

QUESTIONS

OTC - QUESTIONS SECTION

(877) TAN-0052 - (877) 826-0052

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84562-509-00Tan De Soleil Orange Tanning Balm SPF 6100 mL in 1 TUBEOIL1001
84562-509-00Tan De Soleil Orange Tanning Balm SPF 61 in 1 BOXOIL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84562-509TAN DE SOLEIL ORANGE TANNING BALM SPF 6 (HOMOSALATE, OCTISALATE) OIL [TANNING CLUB, LLC]1Current NDC, 2 package rows20240718_5343f359-6074-467c-99bb-f08a7ca2df41.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84562-50984562-509-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YIACT
FERRIC OXIDE RED1K09F3G675IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
Tan De Soleil Orange Tanning Balm SPF 6HOMOSALATE, OCTISALATETANNING CLUB, LLC5343f359-6074-467c-99bb-f08a7ca2df412024-07-17WarningsExact identifier
ndc (package): 84562-509-00
ndc (product): 84562-509
ndc11 (package): 84562050900
spl id: 1d6fdd9f-1b62-095b-e063-6394a90ac467
spl set id: 5343f359-6074-467c-99bb-f08a7ca2df41

Reported adverse events (FAERS/openFDA)#

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