FDA.reportPublic FDA data

Tanning Club Tanning Lotion SPF-8

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 00:15:28

Label at a glance#

ProductTanning Club Tanning SPF-8
Active ingredientAVOBENZONE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. higher SPF gives more sunburn protection retains SPF after 80 minutes of swimming or sweating 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 liberally15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 broad spectrum SPF of 15 or higher and other ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%
Octocrylene 6.00%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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 liberally15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 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

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamine C), Beta-Carotene, Butyloctyl Salicylate, Camellia sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullusn Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Parfum (Fragrance), Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Sodium Stearoyl Glutamate, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum.

QUESTIONS

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84562-512-00Tanning Club Tanning SPF-8150 mL in 1 BOTTLELOTION1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84562-512TANNING CLUB TANNING SPF-8 (AVOBENZONE, OCTOCRYLENE) LOTION [TANNING CLUB, LLC]1Current NDC, 1 package rows20240718_bbf9d61e-f2e6-4fde-baad-c412091c60b6.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84562-51284562-512-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BETA CAROTENE01YAE03M7JIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
CARROTL56Z1JK48BIACT
DIMETHICONE92RU3N3Y1OIACT
DODECANE11A386X1QHIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
ISODODECANEA8289P68Y2IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
POLYSORBATE 207T1F30V5YHIACT
ROSEMARYIJ67X351P9IACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Tanning Club Tanning SPF-8AVOBENZONE, OCTOCRYLENETANNING CLUB, LLCbbf9d61e-f2e6-4fde-baad-c412091c60b62024-07-17WarningsExact identifier
ndc (package): 84562-512-00
ndc (product): 84562-512
ndc11 (package): 84562051200
spl id: 1d6fdd9f-1b8c-095b-e063-6394a90ac467
spl set id: bbf9d61e-f2e6-4fde-baad-c412091c60b6

Reported adverse events (FAERS/openFDA)#

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