SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide liquid

Sun Bum Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sun Bum Mineral Sunscreen Broad Spectrum SPF 50 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 3.4%

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.
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
• do not puncture or incinerate. Contents under pressure. Do not store at room temperature above 120°F.

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
• hold container 4 to6 inches from the skin to apply
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• do not spray directly into face. Spray on hands then apply to face
• do not apply in windy conditions
• use in well-ventilated area
• 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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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 salicylat, helianthus annus (sunflower) seed oil, dicaprylyl carbonate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, polyester-8, sodium stearoyl glutamate, coco-glucoside, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, tocopherol, glycerin, cellulose gum,bentonite, microcrystalline cellulose, caprylyl glycol, silica, polyhydroxystearic acid, citric acid, alumina, bisabolol, sodium gluconate, caprylhydroxamic acid

Questions?

1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-624
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	34 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPANEDIOL (UNII: 5965N8W85T)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCO GLUCOSIDE (UNII: ICS790225B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BANANA (UNII: 4AJZ4765R9)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
BENTONITE (UNII: A3N5ZCN45C)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM OXIDE (UNII: LMI26O6933)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-624-01	170 g in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/22/2021

Labeler - Sun Bum LLC (028642574)