SUN BUM PREMIUM MOISTURIZING SUNSCREEN ROLL ON SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
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 Premium Moisturizing Sunscreen Roll On Lotion SPF 50

Drug Facts

Active ingredients

Avobenzone 3%, Homosalte 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

• shake well before use • apply liberally and spread by hand15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor   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 time in the sun, especially from 10 a.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, hydrated silica, glycerin, polyglyceryl-6 stearate, styrene/acrylates copolymer, acrylates/c 12-22 alkyl methacrylate copolymer, polyster-8, tocopheryl acetate, lysolecithin, sclerotium gum, tetrasodium glutamate diacetate, pullulan, xanthan gum, polyglyceryl-6 behenate, citric acid, phenoxyethanol, ethylhexylglycerin, fragrance

Questions?

1-877-978-6286

Package Labeling:

Bottle3

SUN BUM PREMIUM MOISTURIZING SUNSCREEN ROLL ON SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-642
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)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-642-0188 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2022
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
Document Id: d73e6c85-e9bd-02c1-e053-2995a90ad446
Set id: 8d6c912e-9373-4852-8523-ee7e16f94b8c
Version: 2
Effective Time: 20220204
 
Sun Bum LLC