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

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.

----------

Lip Balm SPF 25 Vanilla Mint

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 on damaged or broken skin.

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

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

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

Lip BalmCremo All-Season Lip Balm SPF 25

CREMO ALL-SEASON LIP BALM SPF 25 VANILLA MINT 
avobenzone, homosalate, octisalate, octocrylene, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71825-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 1000 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 1000 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM40 g  in 1000 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71825-120-617 g in 1 TUBE; Type 0: Not a Combination Product01/06/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/06/2022
Labeler - Cremo Company (078708508)

Revised: 1/2022
Document Id: d4ec08df-8f37-8e0d-e053-2a95a90af728
Set id: d4ec08df-8f36-8e0d-e053-2a95a90af728
Version: 1
Effective Time: 20220106
 
Cremo Company