LIP BALM- avobenzone octinoxate ointment 
Yuyao Jessie Commodity 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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51414-300

Lip Balm

Lips are the softest part of your face and the most exposed to Constant exposure to sun,air,dust,pollution,bacteria and a variety of food items,makes the lips dry,They need a little extra care and protection to retain their softness.These lip balm ingredients are harmless to your tender skin which makes lip balm an absolutely safe product to use

UVB UVA 5G

SPF15 ★★☆☆☆

Medium Medium



Active Ingredients:

Avobenzone 1.5%（w/w）Octinoxate 6.00%（w/w）

USE

Helps prevent sunburn .Provides moderate protection against sunburn.

Warnings:

Stop use if rash occurs

Directions:

Apply liberally before sun exposure and as needed .Children under six months of age: ask a doctor

Inactive ingredients

Hydrogenated Polysobutene, Microcrystalline wax, Caprylic/capric triglyceride, Tridecyl trimellitate. Polybutene. Polyethylene, Ricinus communis (castor) seed oil, Diisostearyl malate, Butyrospermum parkii (shea butter), Ethylhexyl palmitate, Oryzanol, Tocopheryl acetate, Tribehenin, Prunus armeniaca (apricot) kernel oil, Dimethicone, Cyclomethicone, Sorbitan isostearate, Ethylene/VA copolymer, Isododecane, BHT, Lactic acid, Palmitoyl oligopeptide, Propylparaben, Methylparaben, Flavor, Iron oxide*, Mica*, Red 7 lake*, Titanium dioxide*

label of lipbalm
LIP BALM 
avobenzone octinoxate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
SHEA BUTTER (UNII: K49155WL9Y)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GAMMA ORYZANOL (UNII: SST9XCL51M)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
APRICOT SEED OIL (UNII: 54JB35T06A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)  
ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE) (UNII: V9BQI51YUL)  
ISODODECANE (UNII: A8289P68Y2)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
LACTIC ACID (UNII: 33X04XA5AT)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-300-013 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
2NDC:51414-300-024 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
3NDC:51414-300-035 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
4NDC:51414-300-046 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
5NDC:51414-300-057 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
6NDC:51414-300-068 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
7NDC:51414-300-079 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
8NDC:51414-300-0810 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
9NDC:51414-300-0912 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
10NDC:51414-300-1014 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
11NDC:51414-300-116.5 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
12NDC:51414-300-1215 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/19/2010
Labeler - Yuyao Jessie Commodity Co., Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co., Ltd.529892305manufacture(51414-300)

Revised: 7/2022
Document Id: e2ca51a4-c1a3-2294-e053-2995a90a23e6
Set id: a4293449-f627-4dde-be1a-cb401bf18963
Version: 7
Effective Time: 20220701
 
Yuyao Jessie Commodity Co., Ltd.