TANNING CLUB GOLDEN GLOW TANNING OIL SPF-15- avobenzone, octisalate, octocrylene oil

Tanning Club Golden Glow Tanning Oil SPF-15 by

Drug Labeling and Warnings

Tanning Club Golden Glow Tanning Oil SPF-15 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%
Octisalate 4.00%
Octocrylene 5.00%

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:

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Oil, Olea Europaea (Olive) Oil, Parfum (Fragrance), Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate ( Vitamin E), Vitis Vinifera (Grape) Seed Oil.

QUESTIONS

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

Package Labeling:

INGREDIENTS AND APPEARANCE

TANNING CLUB GOLDEN GLOW TANNING OIL SPF-15 
avobenzone, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84562-511
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER (UNII: 4VBL71TY4Y)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT SEED OIL (UNII: 595AO13F11)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCOA (UNII: D9108TZ9KG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84562-511-00	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)