SUN BUM SIGNATURE SPF 30 SUNSCREEN LIP BALM- zinc oxide stick

Sun Bum Signature SPF 30 Sunscreen Lip Balm by

Drug Labeling and Warnings

Sun Bum Signature SPF 30 Sunscreen Lip Balm 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

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 

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-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, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, cera alba (beeswax), euphorbia cerifera (candelilla) wax, 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 or Comments?

Call +1 (877) 978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM SIGNATURE SPF 30 SUNSCREEN LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-277
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)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
WHITE WAX (UNII: 7G1J5DA97F)
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: 69039-277-00	4.25 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2018

Labeler - Sun Bum, LLC (028642574)