SunBum SPF 30 by Sun Bum / Product Quest Mfg. SunBum SPF 30

Drug Details [pdf]

SUNBUM SPF 30- avobenzone 3.00% homosalate 5.00% octisalate 3.00% octocrylene 2.75% oxybenzone 4.00% lotion
Sun Bum

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.

----------

SunBum SPF 30

Active ingredients Purpose

Avobenzone 3.00% Sunscreen
Homosalate 5.00%
Octisalate 3.00%
Octocrylene 2.75%
Oxybenzone 4.00%

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

Front

Back

SUNBUM SPF 30
avobenzone 3.00% homosalate 5.00% octisalate 3.00% octocrylene 2.75% oxybenzone 4.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-552
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
OXYBENZONE (UNII: 95OOS7VE0Y)	4 g in 100 mL
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 SE (UNII: FCZ5MH785I)
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)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
.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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69039-552-05	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/12/2014	08/31/2018
2	NDC: 69039-552-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	03/02/2016	08/31/2018
3	NDC: 69039-552-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2014	08/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/02/2011	08/31/2018

Labeler - Sun Bum (028642574)

Revised: 2/2020

Document Id: 9f80e2d3-806b-47bc-e053-2995a90a4ceb

Set id: 9dd3d1cb-6480-4d5a-bdaf-13b4699cd5e7

Version: 5

Effective Time: 20200226

Sun Bum