![KINESYS BROAD SPECTRUM SPF 30 KIDS ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]](https://medic.hrt.org//dailymed/images/9adea1a4-efa6-4fe1-85e8-ed69fa098a87/SPF30 KIDS 4Oz_US_Front.jpg)
| NDC | 61481-3002-1, 61481-3002-4 |
| Set ID | 9adea1a4-efa6-4fe1-85e8-ed69fa098a87 |
| 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
- Questions or Comments?
- Warnings
-
Directions
- Hold container 4 to 6 inches away from the skin to apply.
- spray 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 conditions
- 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KINESYS BROAD SPECTRUM SPF 30 KIDS ALCOHOL-FREE SUNSCREEN
octinoxate, octocrylene, octisalate, and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-3002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) TOCOPHEROL (UNII: R0ZB2556P8) LEVOMENOL (UNII: 24WE03BX2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61481-3002-4 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2017 2 NDC:61481-3002-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/01/2017 Labeler - Wilc Healthcare Inc (203499140) Registrant - Wilc Healthcare Inc (203499140) Establishment Name Address ID/FEI Business Operations Cosmaceutical Research Laboratory Inc 256797309 manufacture(61481-3002)
