TANNING CLUB TANNING SPF-8- avobenzone, octocrylene lotion

Tanning Club Tanning SPF-8 by

Drug Labeling and Warnings

Tanning Club Tanning SPF-8 by is a Otc medication manufactured, distributed, or labeled by TANNING CLUB, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS

Avobenzone 3.00%
Octocrylene 6.00%

PURPOSE

Sunscreen

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.

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.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

DIRECTIONS:

• 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:

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

INACTIVE INGREDIENTS:

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

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

Package Labeling:

INGREDIENTS AND APPEARANCE

TANNING CLUB TANNING SPF-8 
avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84562-512
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETA CAROTENE (UNII: 01YAE03M7J)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
CARROT (UNII: L56Z1JK48B)
DIMETHICONE (UNII: 92RU3N3Y1O)
DODECANE (UNII: 11A386X1QH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ISODODECANE (UNII: A8289P68Y2)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ROSEMARY (UNII: IJ67X351P9)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84562-512-00	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/27/2024

Labeler - TANNING CLUB, LLC (009119951)