NDC | 55319-790-30 |
Set ID | 93feb534-5aa6-40cd-b96f-8b1e2c923e73 |
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, regularly use a sunscreen with 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
- children under 6 months of age: Ask a doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
-
principal display panel
Tropic Sun
Ultra Sunscreen Spray
Broad spectrum SPF 30
Compare to Coppertone Ultraguard Sunscreen*
SPF 30
Water resistant (80 minutes)
UVA/UVB sunscreen
Paraben free
NET WT 6 OZ (170 g)Tropic Sun
Ultra Sunscreen Spray
Broad spectrum SPF 30
Compare to Coppertone Ultraguard Sunscreen*
SPF 30
Water resistant (80 minutes)
UVA/UVB sunscreen
Paraben free
NET WT 6 OZ (170 g)
-
INGREDIENTS AND APPEARANCE
SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-790 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 25.95 mg in 1 g Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 86.5 mg in 1 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 43.25 mg in 1 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 17.3 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 34.6 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J) glycerin (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-790-30 170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/07/2017 Labeler - Family Dollar Services, Inc. (024472631) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55319-790) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55319-790)