MINERAL LIP TAN LINE SPF 30 BROAD SPECTRUM- sunscreen lipstick

Mineral Lip Tan Line by

Drug Labeling and Warnings

Mineral Lip Tan Line by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 2.8%, Zinc Oxide 1,4%

Purpose

Sunscreens

Uses

helps prevent sunburn

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

Stop use and ask doctor if skin rash occurs

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure & again after 40 minutes of swimming or sweating.

Apply at least every 2 hours.

Sun Protection Measures. To decrease your risk of cancer and early skin aging, regularly use a sunscreen wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm and wear long-sleeved shirts, pants, hats and sunglasses.

Children under 6 months: Ask a doctor

Inactive Ingredients

Beeswax (ORGANIC), Butyrospermum Parkii (ORGANIC Shea Butter), Carmine, Cocos Nucifera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Flavor, Iron Oxides, Jojoba Esters, Mica, Octyldodecyl Oleate, Olea Europaea (ORGANIC Olive) Fruit Oil, Oryzanol, Schinziophyton Rautanenii Kernel Oil (ORGANIC), Silica, Theobroma Grandiflorum Seed Butter (ORGANIC), Tin Oxide, Tocopherol

Other Information

Protect this product from excessive heat and direct sun.

PDP

INGREDIENTS AND APPEARANCE

MINERAL LIP TAN LINE  SPF 30 BROAD SPECTRUM
sunscreen lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
FERRIC OXIDE RED (UNII: 1K09F3G675)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
OLIVE OIL (UNII: 6UYK2W1W1E)
SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E)
TOCOPHEROL (UNII: R0ZB2556P8)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GAMMA ORYZANOL (UNII: SST9XCL51M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-182-32	4.25 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2016

Labeler - Bell International Laboratories, Inc. (967781555)