SUN BUM TINTED SUNSCREEN FACE UVA/UVB BROAD SPECTRUM SPF 30- 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 Tinted Sunscreen Face Lotion UVA/UVB Broad Spectrum SPF 30

Drug Facts

Active ingredient

Titanium dioxide 5.3%

Zinc oxide 2.4%

Purpose

Sunscreen

Uses

Warnings

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 right away.

Directions

Other information

protect this product from excessive heat and direct sun.

Inactive ingredients

cyclopentasiloxane, isopropyl myristate, polyamide-5, stearalkonium hectorite, dimethicone crosspolymer, polysilicone-11, oryza sativa (rice) bran extract, rosemarinus officinalis (rosemary) leaf extract, helianthus annus (sunflower) extract, tocopherol, mica, iron oxides, propylene carbonate, synthetic wax, hydrogen dimethicone, isopropyl titanium triisostearate, aluminum hydroxide, silica silylate, octyldodecyl oleate

Questions?

1-877-978-6286

Package Labeling:

Label2

SUN BUM TINTED SUNSCREEN FACE UVA/UVB BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-621
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE53 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION24 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
RICE BRAN (UNII: R60QEP13IC)  
ROSEMARY (UNII: IJ67X351P9)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-621-011 in 1 BOX02/22/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/22/2021
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
Document Id: d73ebe28-76db-938f-e053-2a95a90a8c3f
Set id: 23d7eb2f-8e2d-4b27-83ba-8d5d60ac9200
Version: 2
Effective Time: 20220204
 
Sun Bum LLC