BULL FROG KIDS SUNSCREEN 35- avobenzone, homosalate, octisalate, oxybenzone, octocrylene lotion

Bull Frog Kids Sunscreen 35 by

Drug Labeling and Warnings

Bull Frog Kids Sunscreen 35 by is a Otc medication manufactured, distributed, or labeled by Sun & Skin Care Research, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate: 12%
Octisalate: 5%
Octocrylene: 5%
Avobenzone: 3%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• If used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  

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.

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

• For use on skin only
• Avoid contact with fabric
• Protect this product from excessive heat and direct sun
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BULL FROG KIDS SUNSCREEN 35 
avobenzone, homosalate, octisalate, oxybenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62802-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	12 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
METHYLPARABEN (UNII: A2I8C7HI9T)
NYLON-12 (UNII: 446U8J075B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARETH-2 (UNII: V56DFE46J5)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
STEARETH-21 (UNII: 53J3F32P58)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PVP/VA COPOLYMER (UNII: D9C330MD8B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62802-362-05	475 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(62802-362)