NDC | 62802-581-01 |
Set ID | ac29da76-f638-4947-8d25-055f1f442dbe |
Category | HUMAN OTC DRUG LABEL |
Packager | Sun & Skin Care Research, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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 out of eyes. 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 or open flames. Keep treated skin away from fire, sparks or flames until dry.
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Directions
- Apply liberally 15 minutes before sun exposure, depress sponge top to initiate product application
- 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
- Apply liberally 15 minutes before sun exposure, depress sponge top to initiate product application
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OCEAN POTION 50 INSTANT DRY KID SPOTSTICK
avobenzone, homosalate, octisalate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62802-581 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CHOLECALCIFEROL (UNII: 1C6V77QF41) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) GLYCERIN (UNII: PDC6A3C0OX) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62802-581-01 19 mL in 1 BOTTLE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2012 Labeler - Sun & Skin Care Research, LLC (849772207) Establishment Name Address ID/FEI Business Operations Sun & Skin Care Research, LLC 849772207 manufacture