SUN BUM FACE 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream 
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 Face 50 Sunscreen Lotion

Drug Facts

Active Ingredients

Avobenzone 3 %, Homosalate 10%

Octisalate 5.%, Octocrylene 10%

Purpose

Sunscreen

Uses

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 swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other Information

Inactive Ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, methylisothiazolinone

Questions or Comments?

call +1 (877) 978-6286

Package Labeling:

Label

SUN BUM FACE 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
DOCOSANOL (UNII: 9G1OE216XY)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-250-0088.7 mL in 1 TUBE; Type 0: Not a Combination Product10/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/05/2017
Labeler - SUN BUM, LLC (028642574)

Revised: 2/2022
Document Id: d72e8d59-6a21-0574-e053-2995a90aadb8
Set id: 4032e623-f958-4e7a-afa3-afc844c6b4e0
Version: 4
Effective Time: 20220204
 
SUN BUM, LLC