Drug Facts

Active Ingredients

Avobenzone 3.00%
Octisalate 5.00%
Homosalate 10.00%

Purpose

Sunscreen

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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: • After 80 minutes of swimming sweating • Immediately after towel • At least every 2 hours • After eating or drinking

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 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Vegetable Oil, Bis-Diglyceryl Polyacyladipate-2, Candelillia (Euphorbia Cerifera) Wax, Sunflower (Helianthus Annuus) Seed Oil, Avocado (Persea Gratissima) Oil, Cocoa (Theobroma Cacao) Seed Butter, Shea (Butyrospermum Parkii) Butter, Peppermint (Mentha Piperita) Oil, Tocopherol, Menthol

Other Information

• Protect the product in this container from excessive heat and direct sun

Questions or comments?

Call 1-888-DRMTLGY

MEDICAL GRADE SKIN CARE

Broad Spectrum SPF 25 Sunscreen

A non-sticky SPF lip balm that protects, soothes, and relieves dry, chapped lips.

Manufactured in USA

DRMTLGY, LLC.
Canoga Park, CA 91304
www.DRMTLGY.com

CRUELTY FREE

BACKED BY SCIENCE

DERMATOLOGIST RECOMMENDED

Packaging

LIPBALM-002

SPF 25 LIP BALM
avobenzone, octisalate, homosalate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83286-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
TOCOPHEROL (UNII: R0ZB2556P8)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83286-002-01	1 in 1 CARTON	01/18/2024
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/18/2024

Labeler - Drmtlgy, LLC (094762235)

DRMTLGY® SPF 25 LIP BALM