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

natural lip balm SPF15(unflavored) by

Drug Labeling and Warnings

natural lip balm SPF15(unflavored) 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

Avobenzone 2%

Homosalate 5%

Octocrylene 3%

Octisalate 3%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF giwes more sunburn protection

Warnings

For external use only

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.

Stop use and ask a doctor if rash occurs.

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.
• 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, BHT

Other information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-029
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
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
BHT (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)
BEESWAX (UNII: 2ZA36H0S2V)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-029-01	4.5 g in 1 CYLINDER; Type 0: Not a Combination Product	12/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/16/2024

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(82953-029)