BROAD SPECTRUM NATURAL SCENT LIP BALM 01- avobenzone, octinoxate, octisalate lipstick 
Cosmuses Cosmetics (Ningbo) Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Broad spectrum SPF15 natural scent lip balm

Drug facts

Active Ingredients

Avobenzone 1%

Octinoxate 2%

Octisalate 1%

Purpose

Sunscreen

Uses

Helps prevent sunburn

warnings

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

Directions

Inactive Ingredients

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

Other information

Protect from excessive heat and direct sun.

82953-005

BROAD SPECTRUM NATURAL SCENT LIP BALM  01
avobenzone, octinoxate, octisalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERESIN (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82953-005-014.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
2NDC:82953-005-026.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
3NDC:82953-005-032.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
4NDC:82953-005-047 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
5NDC:82953-005-0510 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
6NDC:82953-005-0612 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2022
Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
Establishment
NameAddressID/FEIBusiness Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-005)

Revised: 10/2022
Document Id: e9f90310-1974-ffb2-e053-2995a90abe98
Set id: e9f90310-1973-ffb2-e053-2995a90abe98
Version: 1
Effective Time: 20221001
 
Cosmuses Cosmetics (Ningbo) Co., Ltd.