BABY BUM SPF50 MINERAL SUNSCREEN- zinc oxide cream

Baby Bum SPF50 Mineral Sunscreen by

Drug Labeling and Warnings

Baby Bum SPF50 Mineral 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 Ingredients

Zinc oxide 20%

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-sleeve shirts, pants, hats, and sunglasses.

Other Information

• protect this product from excessive heat and direct sun.
• keep outer card for complete directions and warnings

Inactive ingredients

water, cocos nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, methyl dihydroabietate, butyrospermum parkii (shea butter), capryloyl glycerin/sebacic acid copolymer, sodium stearoyl glutamate, cetearyl alcohol, theobroma cacao (cocoa) seed butter, sodium hyaluronate, bisabolol, tocopherol, coco-glucoside, microcrystalline cellulose, cellulose gum, cetyl alcohol, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, sodium gluconate, phenoxyethanol, ethylhexylglycerin, citric acid

Questions?

call 1 877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

BABY BUM SPF50 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCOA BUTTER (UNII: 512OYT1CRR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LEVOMENOL (UNII: 24WE03BX2T)
TOCOPHEROL (UNII: R0ZB2556P8)
COCO GLUCOSIDE (UNII: ICS790225B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CETYL ALCOHOL (UNII: 936JST6JCN)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-255-00	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/11/2017

Labeler - Sun Bum, LLC (028642574)