LIPLUX VANILLA PEPPERMINT SPF 15 BROAD SPECTRUM- sunscreen lipstick
Bell International Laboratories, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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COOLA Liplux SPF 15 Lip Balm Vanilla Peppermint

Active Ingredients

Avobenzone 3.0%, Octisalate 5.0%

Purpose

Sunscreens

Uses

Helps prevent sunburn

If used as directed with othe 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 80 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 with 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

Aloe Barbadensis Leaf Extract, Ascorbyl Palmitate, Beeswax (ORGANIC), Butyrospermum Parkii (ORGANIC Shea Butter), Cocos Nucifera (ORGANIC Coconit) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Diethylhexyl 2,6-Naphthalate, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycine Soja (Soybean) Oil, Helianthus Annuus (ORGANIC Sunflower) Seed Oil, Mentha Piperita (Peppermint) Oil, Octyldodecanol, Persea Gratissima (ORGANIC Avocado) Oil, Rosa Canina Fruit Extract (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Cinensis (ORGANIC Jojoba) Seed Oil, Tocopherol

Other Information

Protect this product from excessive heat and direct sun.

PDP

LIPLUX VANILLA PEPPERMINT SPF 15 BROAD SPECTRUM
sunscreen lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76150-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SOYBEAN OIL (UNII: 241ATL177A)
JOJOBA OIL (UNII: 724GKU717M)
PEPPERMINT OIL (UNII: AV092KU4JH)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
OCTYLDODECANOL (UNII: 461N1O614Y)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
AVOCADO OIL (UNII: 6VNO72PFC1)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
SHEA BUTTER (UNII: K49155WL9Y)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76150-120-14	4.2 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2012	01/01/2021

Labeler - Bell International Laboratories, Inc (967781555)

Revised: 1/2021

Document Id: b8e050a6-211a-125e-e053-2995a90a4a46

Set id: 5d69f494-f85a-ff75-e053-2a91aa0a8542

Version: 2

Effective Time: 20210114

Bell International Laboratories, Inc