Sun Bum 50 by Sun Bum LLC / Product Quest Sun Bum 50

Sun Bum 50 by

Drug Labeling and Warnings

Sun Bum 50 by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC, Product Quest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUN BUM 50- avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% lotion 
Sun Bum LLC

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.

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Sun Bum 50

Active ingredients                            Purpose

Avobenzone 3.00%                           Sunscreen
Homosalate 10.00%
Octisalate 5.00%
Octocrylene 2.75%
Oxybenzone 6.00%

Uses

- helps prevent sunburn
- if used as directed with other sun protection messures ( see Directions) decreases the risk of skin cancer and early skin aging caused by sun.

Warnings

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is 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
  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 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-sleeve shirts, pants, hats, and sunglasses
  children under 6 months: Ask a doctor

Inactive ingredients

Behenyl Alcohol, BHT, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Hydrated Silica, Methylisothiazolinone, PEG-100 Stearate, Polyaminopropyl Biguanide, Polyester-8, Sodium Polyacrylate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene , Copolymer, Water, Xanthan Gum

Product Labeling

SUN BUM 50 
avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.75 mg  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-550-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/23/2012	08/31/2018
2	NDC: 69039-550-05	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/12/2014	08/31/2018
3	NDC: 69039-550-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/12/2014	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/23/2012	08/31/2018

Labeler - Sun Bum LLC (028642574)

Revised: 2/2020

Document Id: 9f80b745-fba9-d888-e053-2995a90a4df5

34390-5

Set id: 9b174cd6-3c1e-41e2-863f-9f575fce5496

Version: 4

Effective Time: 20200226