NATURAL LIP BALM SPF15( PASSION FRUIT) 01- avobenzone,homosalate,octocrylene,octisalate lipstick

natural lip balm SPF15( Passion Fruit) by

Drug Labeling and Warnings

natural lip balm SPF15( Passion Fruit) 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 3%

Homosalate 5%

Avobenzone 2%

Octisalate 3%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only

For external use only

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

OTHER SAFETY INFORMATION

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decreases 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 10a.m.- 2p.m.
wear long-sleeve shirts, pants, hats and sunglasses

Inactive ingredients

Mineral Oil, Beeswax, Ethylhexyl Palmitate, Ozokerite, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Synthetic Wax, Phenoxyethanol,Fragrance, Yellow 5 (Tartrazne), BHT

Questions or Comments?

Call weekdays from 9AM to 5PM EST at 631-231-2300

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATURAL LIP BALM SPF15( PASSION FRUIT)  01
avobenzone,homosalate,octocrylene,octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BHT (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)
BEESWAX (UNII: 2ZA36H0S2V)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
YELLOW 5 (UNII: I753WB2F1M)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-037-01	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(82953-037)