BABY BUM MINERAL SPF50 SUNSCREEN- zinc oxide stick

Baby Bum Mineral SPF50 Sunscreen by

Drug Labeling and Warnings

Baby Bum Mineral 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 ingredient

Zinc oxide 19.2%

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 right away.

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 keep this outer card for complete labeling information

Inactive ingredients

cocos nucifera (coconut) oil, persea gratissima (avocado) oil, limnanthes alba (meadowfoam) seed oil, linum usitatissimum (linseed) seed oil, oryza sativa (rice bran) wax, euphorbia cerifera (candelilla) wax, butyloctyl salicylate, copernicia cerifera (carnauba) wax, ozokerite, butyrospermum parkii (shea butter), oryzanol, fragrance, theobroma cacao (cocoa) seed butter, carthamus tinctorius (safflower) seed oil, jojoba esters, tocopherol, bisabolol

Questions?

call 1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

BABY BUM MINERAL SPF50 SUNSCREEN 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	192 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
LINSEED OIL (UNII: 84XB4DV00W)
RICE BRAN (UNII: R60QEP13IC)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CERESIN (UNII: Q1LS2UJO3A)
SHEA BUTTER (UNII: K49155WL9Y)
GAMMA ORYZANOL (UNII: SST9XCL51M)
COCOA BUTTER (UNII: 512OYT1CRR)
SAFFLOWER OIL (UNII: 65UEH262IS)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-271-00	1 in 1 CARTON	06/13/2018
1		13 g in 1 TUBE; Type 0: Not a Combination Product

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)