SUNSCREEN LIP BALM- ethylhexyl methoxycinnamate, homosalate, polysilicone-15, octocrylene, butyl methoxydibenzoylmethane lipstick 
Guangzhou Tata Biotechnology Co., Ltd.

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SUNSCREEN LIP BALM

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

Sunscreen

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 or comments?

+1-973-907-6739

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

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. lf swallowed, get medical help or contact a Poison
Control Center immediately.

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

Other information protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

SUNSCREEN LIP BALM 
ethylhexyl methoxycinnamate, homosalate, polysilicone-15, octocrylene, butyl methoxydibenzoylmethane lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84066-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29) POLYSILICONE-155 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84066-101-013.2 g in 1 TUBE; Type 0: Not a Combination Product01/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/25/2024
Labeler - Guangzhou Tata Biotechnology Co., Ltd. (699605102)
Registrant - Guangzhou Tata Biotechnology Co., Ltd. (699605102)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Tata Biotechnology Co., Ltd.699605102manufacture(84066-101)

Revised: 2/2024
Document Id: 11a2cf8d-1a04-7ea0-e063-6394a90a73a5
Set id: 0f8e08bf-4b14-bdad-e063-6394a90a34e1
Version: 2
Effective Time: 20240218
 
Guangzhou Tata Biotechnology Co., Ltd.