SUNSCREEN LIP BALM ointment

SUNSCREEN LIP BALM by

Drug Labeling and Warnings

SUNSCREEN LIP BALM by is a Otc medication manufactured, distributed, or labeled by Shenzhen Hengkaifeng Commerce and Trade Co., Ltd, Shenzhen Hengkaifeng Commerce and Trade Co., Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Petrolatum 30%

Purpose

Sunscreen
Skin Protectant

Use

helps prevent sunburn
helps prevent and temporarily protect dry, chapped or
windburned lips

WarningS

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 help prevent
sunburn, not skin cancer or early skin aging.

For external use only.

For external use only.

Stop use and ask a doctor

if rash or irritation develops and lasts.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control
Center right away.

Directions Of Safe Use

apply liberally before sun exposure and as needed
children under 6 months: Ask a doctor

Inactive ingredients

ynthetic Beeswax, Cetyl Alcohol,Paraffin, Mineral Oil,
Polyethylene, Flavor,Cocos Nucifera (Coconut) Oil, Lanolin,
Phenyl Trimethicone, Caprylic/Capric Triglyceride,Titanium
CI 77891, Isopropyl Myristate, Oleyl Alcohol,Tocopherol,
Isopropyl Lanolate, Helianthus Annuus (Sunflower) Seed
Oil, Stearic Acid,BHT, Tocopheryl Acetate,Theobroma Cacao
(Cocoa) Seed Butter, Aloe Barbadensis Leaf Extract,
Terminalia Ferdinandiana Fruit Extract, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive)
Fruit Oil.

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN LIP BALM 
sunscreen lip balm ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84117-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
PARAFFIN (UNII: I9O0E3H2ZE)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84117-004-01	5 g in 1 CANISTER; Type 0: Not a Combination Product	03/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/28/2024

Labeler - Shenzhen Hengkaifeng Commerce and Trade Co., Ltd (444722774)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd		444722774	manufacture(84117-004) , label(84117-004)