LIP BALM SPF15 UNFLAVORED lipstick

Lip Balm SPF15 Unflavored by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Stop Use and Ask a Doctor

if rash occurs

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.

Keep out of reach of children

If swallowed, get medical help or

contact a Poison Control Center right away

Directions

▪ Apply liberally 15 minutes 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 this 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

10am 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).

Questions or Comments?

Call weekdays from 9AM to 5PM EST

at 631-231-2300

Package Label PDP

Lip Balm SPF15 Unflavored (NDC: 72449-415-01)

INGREDIENTS AND APPEARANCE

LIP BALM SPF15 UNFLAVORED 
lip balm spf15 unflavored lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72449-415
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)
BEESWAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72449-415-01	4.2 g in 1 CYLINDER; Type 0: Not a Combination Product	03/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/21/2025

Labeler - LS Promotions Inc (024818391)

Establishment
Name	Address	ID/FEI	Business Operations
LS Promotions Inc		024818391	manufacture(72449-415)