SUN BUM MINERAL SPF 30 TINTED SUNSCREEN FACE- 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 SPF 30 Tinted Sunscreen Face Lotion

Drug Facts

Active ingredients

Titanium dioxide 5.3%

Zinc oxide 2.4%

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

• apply liberally 15 minutes before sun exposure • reapply: • after 40 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

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

Questions?

call 1-877-978-6286

Package Labeling:

Outer PackageUpdated Tube Packaging

SUN BUM MINERAL SPF 30 TINTED SUNSCREEN FACE 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-258
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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
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:69039-258-001 in 1 BOX04/01/2019
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 finalpart35204/01/2019
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
Document Id: d73db8fb-2658-6dd3-e053-2a95a90a13cc
Set id: fff341d5-068b-4aa8-ae2e-a1542e5b933a
Version: 3
Effective Time: 20220204
 
Sun Bum LLC