SUN BUM CLEAR ZINC SPF50 SUNSCREEN- octinoxate, octisalate, octocrylene, zinc oxide cream

Sun Bum Clear Zinc SPF50 Sunscreen by

Drug Labeling and Warnings

Sun Bum Clear Zinc SPF50 Sunscreen 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 Ingredients

Octinoxate 7.5%, Octisalate 5.%, Octocrylene 10%

Zinc oxide 7%

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 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 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-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

water, C12-15 alkyl benzoate, ethylhexyl palmitate, ethylhexyl stearate, cetyl PEG/PPG-10/1 dimethicone,glycerin, cetyl dimethicone, hydrogenated castor oil, hydrated silica, cyclopentasiloxane, polyethylene, aloe barbadensis leaf extract, tocopheryl acetate, theobroma cacao (cocoa) seed butter, beeswax, cyclohexasiloxane, triethoxycaprylylsilane, sodium chloride, DMDM hydantoin, fragrance

Other Information

• protect this product from excessive heat and direct sun.
• keep outer card for complete directions and warnings

Questions or Comments?

call +1 (877) 978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM CLEAR ZINC SPF50 SUNSCREEN 
octinoxate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-251-00	30 mL in 1 TUBE; Type 0: Not a Combination Product	10/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/05/2017

Labeler - SUN BUM, LLC (028642574)