SUN BUM MINERAL SPF30 CONTINUOUS SUNSCREEN- zinc oxide spray

Sun Bum Mineral SPF30 Continuous Sunscreen by

Drug Labeling and Warnings

Sun Bum Mineral SPF30 Continuous 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 ingredient

Zinc oxide 14%

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.

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 temperatures 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 to 6 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 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

water, helianthus annuus (sunflower) oil, butyloctyl salicylate, carthamus tinctorius (safflower) seed oil, caprylic/capric triglyceride, bentonite, methyl dihydroabietate, fragrance, cetearyl alcohol, aloe barbadensis leaf juice, glycerin, microcrystalline cellulose, cellulose gum, coco-glucoside, caprylhydroxamic acid, caprylyl glycol, jojoba esters, bisabolol, tocopherol, polyhydroxystearic acid

Questions?

call 1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM MINERAL SPF30 CONTINUOUS SUNSCREEN 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-274
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SAFFLOWER OIL (UNII: 65UEH262IS)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BENTONITE (UNII: A3N5ZCN45C)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
COCO GLUCOSIDE (UNII: ICS790225B)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-274-00	170 mL in 1 CAN; Type 0: Not a Combination Product	06/13/2018

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

Labeler - Sun Bum LLC (028642574)