Label: BULL FROG WATER ARMOR SUPER 40- meradimate, octinoxate, octisalate, octocrylene, oxybenzone, titanium dixoide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 62802-649-05 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
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.
- Directions
- Other Information
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BULL FROG WATER ARMOR SUPER 40
meradimate, octinoxate, octisalate, octocrylene, oxybenzone, titanium dixoide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62802-649 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) SUCROSE COCOATE (UNII: 3H18P0UK73) PEG-40 SORBITAN STEARATE (UNII: X61U1UH01B) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0) EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) ALUMINUM OXIDE (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62802-649-05 147 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2013 Labeler - Sun & Skin Care Research, LLC (849772207) Establishment Name Address ID/FEI Business Operations Sun & Skin Care Research, LLC 849772207 manufacture(62802-649)