SUNSCREEN- octinoxate,zinc oxide,octisalate stick

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN 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 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.

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INGREDIENTS AND APPEARANCE

SUNSCREEN 
octinoxate,zinc oxide,octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-905-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
2	NDC: 51414-905-02	13 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
3	NDC: 51414-905-03	14 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
4	NDC: 51414-905-04	15 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
5	NDC: 51414-905-05	16 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
6	NDC: 51414-905-06	19 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
7	NDC: 51414-905-07	20 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
8	NDC: 51414-905-08	25 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
9	NDC: 51414-905-09	30 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018
10	NDC: 51414-905-10	2 g in 1 PACKAGE; Type 0: Not a Combination Product	01/05/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-905)