Label: BULL FROG WATER ARMOR SPORT 50- avobenzone, homosalate, octisalate, oxybenzone, octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 62802-683-05 - Packager: Sun & Skin Care Research, LLC
- Category: HUMAN OTC DRUG LABEL
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 March 25, 2014
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- 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 product is swallowed, get medical help or contact a Poison Control Center right away. Do not use near heat or open flame. Keep treated skin away from fire, sparks or flames until dry.
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Directions
- apply liberally 15 minutes before sun exposure.
- 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
BULL FROG WATER ARMOR SPORT 50
avobenzone, homosalate, octisalate, oxybenzone, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62802-683 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62802-683-05 147 g in 1 BOTTLE, SPRAY 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(62802-683)