Sunscreen Stick (Octinoxate,zinc Oxide,octisalate) Spray [Yuyao Jessie Commodity Co.,ltd.] -

SUNSCREEN STICK (OCTINOXATE,ZINC OXIDE,OCTISALATE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]
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NDC	51414-900-01, 51414-900-02, 51414-900-03, 51414-900-04, 51414-900-05, 51414-900-06, 51414-900-07, 51414-900-08, 51414-900-09
Set ID	33e67217-f2bd-47b7-9e36-a2533e2a1ddc
Category	HUMAN OTC DRUG LABEL
Packager	Yuyao Jessie Commodity Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number	PART352

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Active Ingredient

Octinoxate 3%, Octisalate 3%, Zinc Oxide 1%

Purpose

Sunscreen
Use

• Helps prevent sunburn. • If used as directed with other sun protection
measures (see Directions), decreases the risk of skin cancer and early 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 product is swallowed, get
medical help or contact a Poison Control Center right away.

keep out of reach of children

Keep out of reach of children. If product is swallowed, get
medical help or contact a Poison Control Center right away.
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. • Sun Protection Measures. Spending time in the sun increases your
risk of skin cancer and early skin aging. To decrease the risk, regularly use a
sunscreen with a broad spectrum SPF of 15 or higher and other sun protection
measures including: • Limit time in sun, especially from 10 a.m. - 2 p.m. • Wear
long-sleeve shirts, pants, hats, and sunglasses. • Children under six months of age:
Ask a doctor.
Inactive ingredients

Petrolatum, Ozokerite, Mineral Oil, Cocoa Butter, Beeswax,
Isopropyl Isostearate, Hydrogenated Castor Oil, Microcrystalline Wax, Olivate,
Fragrance, Vitamin E.
lebel

INGREDIENTS AND APPEARANCE

SUNSCREEN STICK
octinoxate,zinc oxide,octisalate spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1 g in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Petrolatum (UNII: 4T6H12BN9U)
Mineral oil (UNII: T5L8T28FGP)
Cocoa butter (UNII: 512OYT1CRR)
Isopropyl isostearate (UNII: C67IXB9Y7T)
Hydrogenated castor oil (UNII: ZF94AP8MEY)
Microcrystalline wax (UNII: XOF597Q3KY)
DECYL OLIVATE (UNII: AQH29B0B3H)
1.ALPHA.,24S-DIHYDROXYVITAMIN D2 (UNII: 2900I92Z36)

#	Item Code	Package Description
Packaging
1	NDC:51414-900-01	10 g in 1 PACKAGE
2	NDC:51414-900-02	13 g in 1 PACKAGE
3	NDC:51414-900-03	14 g in 1 PACKAGE
4	NDC:51414-900-04	15 g in 1 PACKAGE
5	NDC:51414-900-05	16 g in 1 PACKAGE
6	NDC:51414-900-06	19 g in 1 PACKAGE
7	NDC:51414-900-07	20 g in 1 PACKAGE
8	NDC:51414-900-08	25 g in 1 PACKAGE
9	NDC:51414-900-09	30 g in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/08/2014

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-900)

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