SUN BUM MINERAL SPF30 SUNSCREEN- zinc oxide stick
Sun Bum LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sun Bum Mineral SPF30 Sunscreen Lip Balm

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

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 : 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, hatsm and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

prunus amydalus 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:

Label6

SUN BUM MINERAL SPF30 SUNSCREEN
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69039-270
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69039-270-00	4.25 g in 1 CARTRIDGE; Type 0: Not a Combination Product	04/15/2018	12/28/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/15/2018	12/28/2018

Labeler - Sun Bum LLC (028642574)

Revised: 12/2018

Document Id: 7e1d16b6-da42-293e-e053-2a91aa0aea0d

Set id: 0607538c-5e8d-40ae-9b39-94565702e9ca

Version: 3

Effective Time: 20181228

Sun Bum LLC