SUN BUM MINERAL SPF30 TINTED SUNSCREEN FACE- titanium dioxide, zinc oxide cream

Sun Bum Mineral SPF30 Tinted Sunscreen Face by

Drug Labeling and Warnings

Sun Bum Mineral SPF30 Tinted Sunscreen Face by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Titanium dioxide 3.2%

Zinc oxide 1.8%

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

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, cucumis sativus (cucumber) fruit extract, butyrospermum parkii (shea butter), oenothera biennis (evening primrose) oil, linum usitatissimum (linseed) seed oil, rosa canina fruit oil, plankton extract, glycerin, mica, iron oxides, propylene carbonate, synthetic wax, hydrogen dimethicone, isopropyl titanium triisostearate, aluminum hydroxide, silica silylate

Questions?

call 1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM MINERAL SPF30 TINTED SUNSCREEN FACE 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-273
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	32 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CUCUMBER (UNII: YY7C30VXJT)
SHEA BUTTER (UNII: K49155WL9Y)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
LINSEED OIL (UNII: 84XB4DV00W)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-273-00	1 in 1 BOX	06/13/2018	01/01/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/13/2018	01/01/2021

Labeler - Sun Bum LLC (028642574)