CARMEX SUN AND SOOTHE MOISTURIZING LIP BALM SPF 30- avobenzone, octisalate, octocrylene kit

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone (3.0%)
Octisalate (5.0%)
Octocrylene (10.0%)

Purpose

Sunscreen

Uses

• helps protect against sunburn and chapped lips

Warnings

Do not use

on damaged or broken skin

Stop use and ask a doctor if:

rash occurs

Keep out of reach of children

Keep out of reach of children

Directions

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients:

petrolatum, beeswax, euphorbia cerifera (candelilla) cera, theobroma cacao (cocoa) seed butter, cetyl esters, lanolin, flavor, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract, tocopherol (vitamin E)

Package Labeling:

INGREDIENTS AND APPEARANCE

CARMEX SUN AND SOOTHE MOISTURIZING LIP BALM SPF 30 
avobenzone, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0099

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0099-1	1 in 1 KIT	03/01/2026

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CYLINDER	4.25 g

Part 1 of 1

CARMEX SUN MOISTURIZING LIP BALM SPF 30 
avobenzone, octisalate, octocrylene salve

Product Information
Item Code (Source)	NDC: 10210-0100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
BEESWAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)
CETYL ESTERS (UNII: D072FFP9GU)
LANOLIN (UNII: 7EV65EAW6H)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0100-1	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2026

Labeler - Carma Laboratories, Inc. (006090153)

Registrant - Carma Laboratories, Inc. (006090153)