Label: KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN- octinoxate, octocrylene, octisalate, and avobenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 61481-3004-1, 61481-3004-4 - Packager: Wilc Healthcare Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 12, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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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
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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
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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
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PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
NDC 61481-3004-1
BROAD SPECTRUM SPF 30
Girl
Alcohol-Free Performance SUNSCREEN
KINeSYS®
Vanilla-Green Tea // Oil-Free
- Clear Spray
- Preservative-Free
BROAD SPECTRUM SPF 30
WATER RESISTANT (80 MINUTES)
1.0 FL OZ (30 mL)
NDC 61481-3004-4
BROAD SPECTRUM SPF 30
Girl
Alcohol-Free Performance SUNSCREEN
KINeSYS®
Vanilla-Green Tea // Oil-Free
Clear Spray
Preservative-FreeBROAD SPECTRUM SPF 30
WATER RESISTANT (80 MINUTES)
4.0 FL OZ (120 mL)
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INGREDIENTS AND APPEARANCE
KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN
octinoxate, octocrylene, octisalate, and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-3004 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:61481-3004-4 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/05/2017 2 NDC:61481-3004-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/05/2017 Labeler - Wilc Healthcare Inc (203499140) Registrant - Wilc Healthcare Inc (203499140) Establishment Name Address ID/FEI Business Operations Cosmaceutical Research Laboratory Inc 256797309 manufacture(61481-3004)