SPF15 LIP BALM- avobenzone octinoxate ointment

SPF15 LIP BALM by

Drug Labeling and Warnings

SPF15 LIP BALM by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd., Yuyao Jessie Commodity Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Octyl Methoxycinnamate 7.5%

Oxybenzone 3.0%

Octyl Salicylate2.0%

PURPOSE

sunscreen

USE

Helps prevent sunburn .helps moisturize the lip

Warnings:

For extenrnal use only

stop use and ask a doctor if rash or irritation develops and lasts

Children under 36 months of age:ask a doctor before use

Keep out of reach of children,if swallowed,get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally before sun exposure and as needed

Inactive ingredients

Castor oil, caprylic Capric Triglyceriydes,Propylparaben Insoluble Saccharin,White bees wax,candelilla wax,menthol,natural and artificail flavor,vitamin E acetate,aloe vera oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF15 LIP BALM 
avobenzone octinoxate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CASTOR OIL (UNII: D5340Y2I9G)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WHITE WAX (UNII: 7G1J5DA97F)
CANDELILLA WAX (UNII: WL0328HX19)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-908-03	3 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
2	NDC: 51414-908-04	4 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
3	NDC: 51414-908-05	4.5 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
4	NDC: 51414-908-06	5 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
5	NDC: 51414-908-07	6 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
6	NDC: 51414-908-08	6.5 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
7	NDC: 51414-908-09	7 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
8	NDC: 51414-908-10	8 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
9	NDC: 51414-908-11	9 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
10	NDC: 51414-908-12	10 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
11	NDC: 51414-908-02	2.5 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
12	NDC: 51414-908-01	2 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
13	NDC: 51414-908-13	11 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
14	NDC: 51414-908-14	12 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
15	NDC: 51414-908-15	14 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019
16	NDC: 51414-908-16	15 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/04/2019

Labeler - Yuyao Jessie Promotional Products Co., Ltd. (529892305)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Promotional Products Co., Ltd.		529892305	manufacture(51414-908)