TAN DE SOLEIL ORANGE TANNING BALM SPF 6- homosalate, octisalate oil

Tan De Soleil Orange Tanning Balm SPF 6 by

Drug Labeling and Warnings

Tan De Soleil Orange Tanning Balm SPF 6 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

Homosalate 3.00%

Octisalate 4.0%

PURPOSE

Sunscreen

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

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 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:

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

INACTIVE INGREDIENTS:

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

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

Package Labeling:

INGREDIENTS AND APPEARANCE

TAN DE SOLEIL ORANGE TANNING BALM SPF 6 
homosalate, octisalate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84562-509
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84562-509-00	1 in 1 BOX	07/01/2024
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/01/2024

Labeler - TANNING CLUB, LLC (009119951)