LIP BALM SPF15 VANILLA- lip balm spf15 lipstick

Lip Balm SPF15 Vanilla by

Drug Labeling and Warnings

Lip Balm SPF15 Vanilla by is a Otc medication manufactured, distributed, or labeled by LS Promotions Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Lip Balm SPF15 Vanilla

Drug Facts

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

Stop Use and Ask a Doctor

if rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children

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

Directions

• Apply liberally 15 minuts before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months of age: Ask a doctor

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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 AM to 2 PM
• Wear long sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax, Petrolatum, Cerifera (Candelilla Wax), Flavor.

Questions or Comments?

Call weekdays from 9 AM to 5PM EST at 631-231-2300

LB100I Label

LB100I Vanilla Label (NDC: 72449-408-01)

INGREDIENTS AND APPEARANCE

LIP BALM SPF15 VANILLA 
lip balm spf15 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72449-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.2 g  in 4.2 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.3 g  in 4.2 g

Inactive Ingredients
Ingredient Name	Strength
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ESTERS WAX (UNII: D072FFP9GU)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
BEESWAX (UNII: 2ZA36H0S2V)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72449-408-01	4.2 g in 1 CYLINDER; Type 0: Not a Combination Product	03/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/18/2025

Labeler - LS Promotions Inc (024818391)

Establishment
Name	Address	ID/FEI	Business Operations
LS Promotions Inc		024818391	manufacture(72449-408)