NDC | 51414-907-01, 51414-907-02, 51414-907-03, 51414-907-04, 51414-907-05, 51414-907-06, 51414-907-07, 51414-907-08, 51414-907-09, 51414-907-10, 51414-907-11, 51414-907-12, 51414-907-13, 51414-907-14, 51414-907-15, 51414-907-16, 51414-907-17, 51414-907-18, 51414-907-19, 51414-907-20 |
Set ID | 77220c16-6bd6-8780-e053-2991aa0ad2b3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Yuyao Jessie Commodity Co.,Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredient
- Use
- WARNINGS
-
Directions
•Apply generously & evenly 15 minutes before sun exposure.
•Children under 6 months of age: Ask a doctor
•Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease this risk,regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
•limit time in the sun,especially from 10 a.m. -2 p.m.
•wear long-sleeved shirts,pants, hats, and sunglasses.
•Reapply at least every 2 hours
•use a water resistant sunscreen if swimming orsweating. - Inactive ingredients
- lebel
-
INGREDIENTS AND APPEARANCE
SUNSCREEN
octocrylene ,homosalate,avobenzone,octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51414-907 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5) .BETA.-BISABOLOL (UNII: LP618AV2EA) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) WATER (UNII: 059QF0KO0R) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BEHENETH-25 METHACRYLATE (UNII: 108R05PWG6) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51414-907-01 5 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 2 NDC:51414-907-02 8 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 3 NDC:51414-907-03 10 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 4 NDC:51414-907-04 15 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 5 NDC:51414-907-05 20 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 6 NDC:51414-907-06 30 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 7 NDC:51414-907-07 40 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 8 NDC:51414-907-08 50 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 9 NDC:51414-907-09 60 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 10 NDC:51414-907-10 80 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 11 NDC:51414-907-11 90 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 12 NDC:51414-907-12 100 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 13 NDC:51414-907-13 120 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 14 NDC:51414-907-14 150 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 15 NDC:51414-907-15 200 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 16 NDC:51414-907-16 240 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 17 NDC:51414-907-17 300 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 18 NDC:51414-907-18 360 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 19 NDC:51414-907-19 400 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 20 NDC:51414-907-20 500 g in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/12/2012 Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305) Establishment Name Address ID/FEI Business Operations Yuyao Jessie Commodity Co.,Ltd. 529892305 manufacture(51414-907)