CREMO ALL-SEASON LIP BALM SPF 25 VANILLA MINT- avobenzone, homosalate, octisalate, octocrylene, petrolatum ointment

Cremo All-Season Lip Balm SPF 25 Vanilla Mint by

Drug Labeling and Warnings

Cremo All-Season Lip Balm SPF 25 Vanilla Mint by is a Otc medication manufactured, distributed, or labeled by Cremo Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Petrolatum 40%

Purpose

Sunscreen

Skin Protectant

Uses

Helps Prevent sunburn and chapped lips.

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

If rash occurs, discontinue use and consult a health care practitioner

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

Directions

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months, consult a doctor.

Inactive Ingredients

Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Flavor, Polyglyceryl-3 Beeswax, Lanolin, C18-38 Alkyl Hydroxystearoyl Stearate, Hydrogenated Poly (C6-14 Olefin), Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Cannabis Sativa Seed Oil*, Bisabolol, Tocopherol.
*Organic

Other Information

Protect product from excessive heat and direct sunlight. You may report a serious adverse reaction from using this product to Cremo Company at 1-800-853-1762.

Questions?

1-800-853-1762 www.cremocompany.com

PRINCIPAL DISPLAY PANEL

Cremo All-Season Lip Balm SPF 25

INGREDIENTS AND APPEARANCE

CREMO ALL-SEASON LIP BALM SPF 25 VANILLA MINT 
avobenzone, homosalate, octisalate, octocrylene, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71825-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 1000 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 1000 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	40 g  in 1000 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
LEVOMENOL (UNII: 24WE03BX2T)
LANOLIN (UNII: 7EV65EAW6H)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71825-120-61	7 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/06/2022

Labeler - Cremo Company (078708508)