SUNSCREEN LIP BALM- ethylhexyl methoxycinnamate, homosalate, polysilicone-15, octocrylene, butyl methoxydibenzoylmethane lipstick

SUNSCREEN LIP BALM by

Drug Labeling and Warnings

SUNSCREEN LIP BALM by is a Otc medication manufactured, distributed, or labeled by Guangzhou Tata Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Ethylhexyl Methoxycinnamate 7%
Homosalate 6 %
Polysilicone-15 5%
Octocrylene 5%
Butyl Methoxydibenzoylmethane 2%

PURPOSE

Sunscreen

INACTIVE INGREDIENT

lnactive ingredients：Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax，Fragrance, Tocopherol， Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil，12-Hexanediol, Citric Acid

QUESTIONS

Questions or comments?

+1-973-907-6739

INDICATIONS & USAGE

helps prevent sumburn
if used as directed with other sun protection measures, (see Directions) decreases therisk of skin cancer and early skin aging caused by the sun

WARNINGS

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. lf swallowed, get medical help or contact a Poison
Control Center immediately.

DOSAGE & ADMINISTRATION

Directions
apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts,pants,hats and sunglasses

STORAGE AND HANDLING

Other information protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN LIP BALM 
ethylhexyl methoxycinnamate, homosalate, polysilicone-15, octocrylene, butyl methoxydibenzoylmethane lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84066-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29)	POLYSILICONE-15	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)
CERESIN (UNII: Q1LS2UJO3A)
JOJOBA OIL (UNII: 724GKU717M)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)	18.91 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84066-101-01	3.2 g in 1 TUBE; Type 0: Not a Combination Product	01/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/25/2024

Labeler - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Registrant - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Tata Biotechnology Co., Ltd.		699605102	manufacture(84066-101)