SUNSCREEN LIP BALM SPF15- octinoxate, avobenzone, octisalate lipstick

Sunscreen Lip Balm SPF15 by

Drug Labeling and Warnings

Sunscreen Lip Balm SPF15 by is a Otc medication manufactured, distributed, or labeled by Dongguan Taimeng Accessories Co., Ltd., Dongguan Taimeng Accessories Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 2%,Avobenzone 1%,Octisalate 1%

Purpose

Sunscreen

Uses

- helps protect against sunbumn and chapped lips

- higher SPF gives more sunburn protection

Warnings

1. Skin Cancer/Skin Aging Alert: Spending time in the sun increasesyour risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skinaging.

2. For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water toremove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

lf swallowed, get medical help orcontact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

reapply: at least every 2 hours

children under 2 years of age: ask a doctor

Inactive ingredients

Ozokerite, Polyisobutene,Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea)Butter,Microcrystalline Wax, Phenoxyethanol, Fragrance(Parfum),BHT

87353-001

INGREDIENTS AND APPEARANCE

SUNSCREEN LIP BALM SPF15 
octinoxate, avobenzone, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87353-001
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BHT (UNII: 1P9D0Z171K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
BEESWAX (UNII: 2ZA36H0S2V)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87353-001-01	14 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/22/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/22/2026

Labeler - Dongguan Taimeng Accessories Co., Ltd. (548236037)

Establishment
Name	Address	ID/FEI	Business Operations
Dongguan Taimeng Accessories Co., Ltd		548236037	manufacture(87353-001)