Label: BULLFROG SPF 50 SUNSCREEN INSECT REPELLENT- avobenzone, homosalate, octisalate, and octinoxate spray
- NDC Code(s): 13630-0215-4
- Packager: Prime Packaging Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 18, 2022
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
-
SPL UNCLASSIFIED SECTION
Flammable
- do not use near heat,flame or while smoking
- avoid long-term storage above 104ºF (40ºC)
- do not puncture or incinerate
- contents under pressure
- do not store at temperatures above 120ºF (49ºC). Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.
- Directions
- Other information
- Inactive ingredients
- Question or comments?
- Bullfrog SPF 50 Sunscreen + Insect Repellent
-
INGREDIENTS AND APPEARANCE
BULLFROG SPF 50 SUNSCREEN INSECT REPELLENT
avobenzone, homosalate, octisalate, and octinoxate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0215 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 66.38 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 26.55 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 88.5 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 44.25 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 44.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Product Characteristics Color yellow (Very Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0215-4 176 mL in 1 CAN; Type 0: Not a Combination Product 12/03/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/03/2021 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0215) , analysis(13630-0215) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0215) , label(13630-0215)