SUN BUM FACE 50 PREMIUM SUNSCREEN SPF 50- avobenzone, homosalte, octisalate, octocrylene lotion 
Wasatch Product Development, 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 Premium Sunscreen Lotion SPF 50

Active ingredients Purpose

Avobenzone 3 %, Homosalate 10%

Octisalate 5.%, Octocrylene 10% Sunscreen

Uses

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Stop use and ask a doctor if rash occurs.

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.

Directions

Other information

protect this product from excessive heat and direct sun.

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

Sun Bum

Face 50

Premium Sunscreen Face Lotion

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

Lightweight

Breakout Free

Fragrance Free, Oxbenzone Free

Dermatologist Tested

Gluten Free

Vegan

3 FL OZ / 88 mL

SPF 50 face 3 oz

SUN BUM FACE 50 PREMIUM SUNSCREEN SPF 50 
avobenzone, homosalte, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 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)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44717-080-0188 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/01/2023
Labeler - Wasatch Product Development, LLC (962452533)

Revised: 2/2023
Document Id: f4ac746a-a50b-8041-e053-2a95a90a8ea6
Set id: f4ac746a-a50a-8041-e053-2a95a90a8ea6
Version: 1
Effective Time: 20230214
 
Wasatch Product Development, LLC