SUN BUM MINERAL SPF30 SUNSCREEN- zinc oxide stick

Sun Bum Mineral SPF30 Sunscreen by

Drug Labeling and Warnings

Sun Bum Mineral SPF30 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 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 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

prunus amygdalus dulcis (sweet almond) oil, cera alba (beeswax), simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, fragrance, argania spinosa kernel (argan) oil, caprylic/capric triglyceride, tocopheryl acetate, copernicia cerifera (carnauba) wax, tocopherol, glycine soja (soybean) oil, glyceryl caprylate, bisabolol, polyhydroxystearic acid, polyglyceryl-3-polyricinoleate, isostearic acid, lecithin, glyceryl undecylenate

Questions?

call 1 (877) 978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM MINERAL SPF30 SUNSCREEN 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
WHITE WAX (UNII: 7G1J5DA97F)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
CANDELILLA WAX (UNII: WL0328HX19)
ARGAN OIL (UNII: 4V59G5UW9X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
LEVOMENOL (UNII: 24WE03BX2T)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-275-00	4.25 g in 1 TUBE; 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)