PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, 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 SPF 50 Premium Moisturizing Sunscreen Lotion

Active ingredients Purpose: Sunscreen

Avobenzone 3%, Homosalate 10%,
Octisalate 5%, Octocrylene 10%

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

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:

• limit your time in the sun, especially from 10a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Protect this product from excessive heat and direct sun

Inactive ingredients

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

Sun Bum

50

Premium Moisturizing Sunscreen Lotion

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

Gluten Free and Vegan

Antioxidant Enriched (Vitamin E)

Dermatologist Tested

6 FL OZ / 177 mL

SPF 50 tube sunscreen lotion

PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-069
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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
DIMETHICONE 100 (UNII: RO266O364U)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
DOCOSANOL (UNII: 9G1OE216XY)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44717-069-01177 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: f43408a7-8f85-3a41-e053-2995a90a0bdb
Set id: f434089c-126f-441c-e053-2995a90ab0c7
Version: 1
Effective Time: 20230206
 
Wasatch Product Development, LLC