SUNSCREEN STICK- octinoxate,zinc oxide,octisalate spray 
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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SUNSCREEN STICK

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

image

SUNSCREEN STICK 
octinoxate,zinc oxide,octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-900-0110 g in 1 PACKAGE
2NDC:51414-900-0213 g in 1 PACKAGE
3NDC:51414-900-0314 g in 1 PACKAGE
4NDC:51414-900-0415 g in 1 PACKAGE
5NDC:51414-900-0516 g in 1 PACKAGE
6NDC:51414-900-0619 g in 1 PACKAGE
7NDC:51414-900-0720 g in 1 PACKAGE
8NDC:51414-900-0825 g in 1 PACKAGE
9NDC:51414-900-0930 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/08/2014
Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-900)

Revised: 5/2014
Document Id: 4bdf44a4-e969-4533-870e-e98ca64bc97b
Set id: 33e67217-f2bd-47b7-9e36-a2533e2a1ddc
Version: 1
Effective Time: 20140508
 
Yuyao Jessie Commodity Co.,Ltd.