BURND- homosalate, octinoxate, zinc oxide lotion

burnd by

Drug Labeling and Warnings

burnd by is a Otc medication manufactured, distributed, or labeled by BURND LLC, Fragrance Manufacturing,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 8.0 %

Octinoxate 7.5%

Zinc Oxide 8.1%

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 useon damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctorif rash occurs.

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 or sweating.
Immediately after towel drying. At least every 2 hours.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk ofskin 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. to 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months of age: Ask a doctor.

Other Information:

• Protect the product in this container from excessive heat and direct sun.
• May stain some fabrics.

Inactive Ingredients:

Aluminum Starch Octenylsuccinate,Ascorbyl Palmitate, Bis-PEG-12 Dimethicone Beeswax,Caprylhydroxamic Acid, Caprylyl Glycol, Cyclopentasiloxane,Decyl Glucoside, Diethylhexyl Sebacate, Ethylhexylglycerin,Hydrogenated Castor Oil, Methylpropanediol, PEG/PPG-20/15 Dimethicone, PEG-30 Dipolyhydroxystearate,Polysilicone-11, Propanediol, Silica, Sodium Chloride,Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURND 
homosalate, octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85455-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL SEBACATE (UNII: U9LS47Q72Q)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85455-100-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/09/2025

Labeler - BURND LLC (119485887)

Registrant - Fragrance Manufacturing,Inc. (793406000)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing,Inc.		793406000	manufacture(85455-100)