REEF SAFE LIP BALM 01- avobenzone,homosalate,octocrylene,octisalate lipstick

Reef safe lip balm by

Drug Labeling and Warnings

Reef safe lip balm 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%

Octisalate 3%

Octocrylene 3%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Helps prevent and temporarily protect dry, chapped or windblown lips.

WARNINGS

For external use only

Skin cancer/ skin aging alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not cancer or early aging.

For external use only

Stop use and ask a doctor: if rash or irritation develops and persists.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply librerally before sun exposure and as needed.

Children under 6 months or age: ask a doctor before use.

Inactive ingredients

Mineral Oil,Ozokerite, Petrolatum, Triethoxycaprylylsilane, Microcrystalline Wax, Beeswax, Tridecyl Trimellitate, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Tocopherol, Phenoxyethanol,Fragrance, BHT

Questions?

Tekweld 45 Rabro Dr.Hauppauge, NY 11788

www.tekweld.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REEF SAFE LIP BALM  01
avobenzone,homosalate,octocrylene,octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-049
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
PETROLATUM (UNII: 4T6H12BN9U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BHT (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)
BEESWAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-049-01	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product	01/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2026

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(82953-049)