SUNSCREEN STICK SPF30( CB400) 01- avobenzone,homosalate,octocrylene,octisalate lipstick

Sunscreen Stick SPF30( CB400) by

Drug Labeling and Warnings

Sunscreen Stick SPF30( 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

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

warnings

For external use only.

Do not use

Do not use on damaged or broken skin.

When using this product

when using this product keep out of eyes, rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is 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

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

other information

protect form excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN STICK SPF30( CB400)  01
avobenzone,homosalate,octocrylene,octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BHT (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)
BEESWAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYL PALMITATE (UNII: UYY8LE6Q5Y)
FRAGRANCE 13576 (UNII: 5EM498GW35)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-043-01	2 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(82953-043)