![KINESYS BROAD SPECTRUM SPF 50 ALCOHOL FREE SUNSCREEN (OCTOCRYLENE, OCTINOXATE, HOMOSALATE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]](https://medic.hrt.org//dailymed/images/998fe524-6469-4c9b-889b-3191882149ce/1.jpg)
![KINESYS BROAD SPECTRUM SPF 50 ALCOHOL FREE SUNSCREEN (OCTOCRYLENE, OCTINOXATE, HOMOSALATE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]](https://medic.hrt.org//dailymed/images/998fe524-6469-4c9b-889b-3191882149ce/New label.jpg)
| NDC | 61481-3005-1, 61481-3005-4 |
| Set ID | 998fe524-6469-4c9b-889b-3191882149ce |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Wilc Healthcare Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
-
Uses
- 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
-
Directions
- Hold container 4 to 6 inches from the skin to apply
- Apply generously and spread evenly by hand 15 minutes before sun exposure
-
Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Do not spray directly onto the face. Spray into hands, and apply to the face.
- Do not apply in windy condition
- Use in well-ventilated area
-
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 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-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
- Inactive Ingredients
- Other Information
- Questions or Comments?
-
PRINCIPAL DISPLAY PANEL
NDC 61481-3005-1
BROAD SPECTRUM SPF 50
Alcohol-Free
Performance Sunscreen
KINeSYS
Fragrance-Free//Oil-Free
- Clear Spray
- Presrvative-Free
BROAD SPECTRUM SPF50
WATER RESISTANT (80 MINUTES)
1 FL OZ(30 mL)
NDC 61481-3005-4
BROAD SPECTRUM SPF 50
Alcohol-Free
Performance Sunscreen
KINeSYS
Fragrance-Free//Oil-Free
- Clear Spray
- Presrvative-Free
BROAD SPECTRUM SPF50
WATER RESISTANT (80 MINUTES)
4 FL OZ (120 mL)
-
INGREDIENTS AND APPEARANCE
KINESYS BROAD SPECTRUM SPF 50 ALCOHOL FREE SUNSCREEN
octocrylene, octinoxate, homosalate, octisalate, and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-3005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 100 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8) Diphenylsiloxy Phenyl Trimethicone (UNII: I445L28B12) Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9) Octyldodecanol (UNII: 461N1O614Y) Tocopherol (UNII: R0ZB2556P8) Levomenol (UNII: 24WE03BX2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61481-3005-4 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/12/2017 2 NDC:61481-3005-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/27/2015 Labeler - Wilc Healthcare Inc (203499140) Registrant - Wilc Healthcare Inc (203499140) Establishment Name Address ID/FEI Business Operations Cosmaceutical Research Laboratory Inc 256797309 manufacture(61481-3005)