NDC | 55319-764-21, 55319-764-34 |
Set ID | eccbe598-e07f-4fde-883b-48fd37115e7a |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Dollar Services, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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 this risk use reqularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especiallyu from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor
- Other Information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
-
INGREDIENTS AND APPEARANCE
SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-764 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.6 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 119 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45.9 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 45.9 mg in 1 mL oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone 55.08 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) BENZYL ALCOHOL (UNII: LKG8494WBH) TOCOPHEROL (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) OLETH-3 (UNII: BQZ26235UC) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-764-21 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2016 2 NDC:55319-764-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/12/2016 Labeler - Family Dollar Services, Inc (024472631) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55319-764) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55319-764)