Label: BULLFROG SPF50 WATER SPORT- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 70281-324-13 - Packager: SolSkyn Personal Care 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 February 16, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- re-apply:
• after 80 minutes of swimming or sweating
• 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months: ask a doctor
- apply liberally 15 minutes before sun exposure
- Other information
-
Inactive Ingredients
Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Macrocystis Pyrifera Extract, Phenoxyethanol, Polyester-8, Polyisobutene, Propylene Glycol, Silica, Sorbitan Oleate, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BULLFROG SPF50 WATER SPORT
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-324 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 mg in 100 mg HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mg in 100 mg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 mg in 100 mg OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mg in 100 mg Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYPROMELLOSES (UNII: 3NXW29V3WO) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-324-13 147 mg in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/15/2015 Labeler - SolSkyn Personal Care LLC (080010329)