Label: SUNSCREEN STICK- octinoxate,zinc oxide,octisalate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 51414-900-01, 51414-900-02, 51414-900-03, 51414-900-04, view more51414-900-05, 51414-900-06, 51414-900-07, 51414-900-08, 51414-900-09 - Packager: Yuyao Jessie Commodity Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 8, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Use
- WARNINGS
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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
- lebel
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INGREDIENTS AND APPEARANCE
SUNSCREEN STICK
octinoxate,zinc oxide,octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51414-900 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:51414-900-01 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 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(51414-900)
