PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 70- 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.

----------

Sun Bum SPF 70 Premium Moisturizing Sunscreen Lotion

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%. Purpose: 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

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

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

water,cetyl palmitate, hydrated silica, acrylates/C12-22 alkyl methacrylate copolymer, caprylyl methicone, styrene/acrylates copolymer, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, polyester-8, trideceth-6, dimethicone, ethylhexyl stearate, fragrance, phenoxyethanol, dimethyl capramide, sodium polyacrylate, trimethylsiloxysilicate, xanthan gum, BHT, dipotassium glycyrrhizate, tocopheryl acetate, ethylhexylglycerin, tetrasodium glutamate diacetate

Sun Bum

70

Premium Moisturizing Sunscreen Lotion

Broad Spectrum SPF 70

Water Resistant (80 Minutes)

Gluten Free and Vegan

Antioxidant Enriched (Vitamin E)

Dermatologist Tested

6 FL OZ / 177 mL

Moist sunscreen SPF 70 lotion

PREMIUM MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 70 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-070
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) HOMOSALATE15 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
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
DIMETHICONE 100 (UNII: RO266O364U)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44717-070-01177 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: f411a763-6f9f-9566-e053-2995a90a0a01
Set id: f4369f2f-fdc3-e48e-e053-2995a90a07f7
Version: 3
Effective Time: 20230206
 
Wasatch Product Development, LLC