Label: OCEAN POTION INTELL MIST 50 KIDS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 62802-301-06 - Packager: Sun & Skin Care Research, LLC
- 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 18, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep away from face to avoid breathing in. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Flammable Do not use near heat, flame or while smoking. Avoid long term storage above 104°F (40°C). Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store in temperatures above 120°F.
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Directions
- spray evenly and liberally on all exposed areas 15 minutes before sun exposure. Ensure skin is completely covered with product
- hold can 4-6 inches away from the skin to apply
- do not spray directly on face. Spray on hands then apply to face
- do not apply in windy conditions. Use in a well-ventilated area
- reapply after 80 minutes of swimming or sweating and 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants hats and sunglasses.
- children under 6 months: Ask a doctor
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OCEAN POTION INTELL MIST 50 KIDS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62802-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CHOLECALCIFEROL (UNII: 1C6V77QF41) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) GLYCERIN (UNII: PDC6A3C0OX) DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62802-301-06 177 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2014 Labeler - Sun & Skin Care Research, LLC (849772207) Establishment Name Address ID/FEI Business Operations Sun & Skin Care Research, LLC 849772207 manufacture(62802-301)
