LIP BALM SPF15( CB400) 01- octocrylene,octisalate lipstick

lip balm SPF15( CB400) by

Drug Labeling and Warnings

lip balm SPF15( CB400) by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octocrylene 8%

Octisalate 4%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

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 help or contact a Poison Control Center right away.

Directions

• Apply liberally 15minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months of age: Ask a doctor.

Inactive ingredients

Beeswax, Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Tocopherol, Phenoxyethanol, Fragrance

other information

Protect from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIP BALM SPF15( CB400)  01
octocrylene,octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
BEESWAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-042-01	4.5 g in 1 CYLINDER; Type 0: Not a Combination Product	03/27/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/27/2025

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-042)