SPF15 LIP BALM- octocrylene,octyl salicylate 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Octocrylene 8%, Octyl Salicylate 4%

PURPOSE

sunscreen

USE

Helps prevent sunbum.Higher SPF gives more sunbum protection.

If used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and earty skin aging caused
by the sun.

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

Directions:

Apply lberallyly 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every two hours.
Children under 6 months: Ask a doctor.
Sunprotection Measures. Spending time in the sun increases your risk of skin cancer and early skin
aging. To decrease this risk, regulaly use a sunscreen with a Broad SpectumSPFof 15 or higher and other
sunprotectionmeasures icluding;Limit time in the sun, especilly from 10am-2p.m.Wear
long-sleewed shirts, pants, hats, and sunglasses.

Inactive ingredients

Mineral oil, Petrolatum, Ozokerite, Polyisobutylene, Butyrospermum Parki Butter, Bees wax,
Cera Microcristallina, Phenoxyethanol, Fragrance, Tocopheryl Acetate
MAY CONTAIN: RED 40 CI 16035 ,BLUE 1 CI 42090, ELLOW5 CI 19140

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF15 LIP BALM 
octocrylene,octyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-910
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
YELLOW WAX (UNII: 2ZA36H0S2V)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERESIN (UNII: Q1LS2UJO3A)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-910-03	3 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
2	NDC: 51414-910-04	4 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
3	NDC: 51414-910-05	4.5 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
4	NDC: 51414-910-06	5 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
5	NDC: 51414-910-07	6 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
6	NDC: 51414-910-08	6.5 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
7	NDC: 51414-910-09	7 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
8	NDC: 51414-910-10	8 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
9	NDC: 51414-910-11	9 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
10	NDC: 51414-910-12	10 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
11	NDC: 51414-910-02	2.5 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
12	NDC: 51414-910-01	2 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
13	NDC: 51414-910-13	11 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
14	NDC: 51414-910-14	12 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
15	NDC: 51414-910-15	14 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
16	NDC: 51414-910-16	15 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
17	NDC: 51414-910-17	3.5 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
18	NDC: 51414-910-18	20 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
19	NDC: 51414-910-19	25 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
20	NDC: 51414-910-20	30 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
21	NDC: 51414-910-21	50 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/18/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Promotional Products Co., Ltd.		529892305	manufacture(51414-910)