SUN BUM MINERAL SUNSCREEN ROLL ON SPF 50- titanium dioxide, zinc oxide 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 Mineral Sunscreen Roll On Lotion SPF 50

Drug Facts

Active ingredients

Titanium dioxide 3.4%, Zinc oxide 16%

Purpose

Sunscreen

Uses

• helps prevent sunburn • if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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, butyloctyl salicylate, dicaprylyl carbonate, isononyl isononanoate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, bisabolol, bentonite, cellulose gum, C18-21 alkane, caprylyl glycol, citric acid, coco-glucoside, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodium stearoyl glutamate, tocopherol, polyester-8, silica, alumina, caprylhydroxamic acid

Questions?

1-877-978-6286

Package Labeling:

Bottle2

SUN BUM MINERAL SUNSCREEN ROLL ON SPF 50 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-641
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE34 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
PROPANEDIOL (UNII: 5965N8W85T)  
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BANANA (UNII: 4AJZ4765R9)  
LEVOMENOL (UNII: 24WE03BX2T)  
BENTONITE (UNII: A3N5ZCN45C)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
C18-C21 ALKANE (UNII: 33822S0M40)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO GLUCOSIDE (UNII: ICS790225B)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-641-0188 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: d73e77bb-4167-11c8-e053-2995a90a7627
Set id: 81e06c01-26ee-425f-9b77-f189563f9127
Version: 2
Effective Time: 20220204
 
Sun Bum LLC