BABY BUM SPF50 MINERAL SUNSCREEN- zinc oxide cream 
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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Baby Bum SPF50 Mineral Sunscreen Lotion

Drug Facts

Active Ingredients

Zinc oxide 20%

Purpose

Sunscreen

Uses

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

Other Information

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:

88mL Label

Package Labeling:69039-255-01

Bottle

BABY BUM SPF50 MINERAL SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-255-0088 mL in 1 TUBE; Type 0: Not a Combination Product10/11/2017
2NDC:69039-255-0115 mL in 1 PACKET; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/11/2017
Labeler - Sun Bum, LLC (028642574)

Revised: 2/2022
Document Id: d73e1de4-1087-baed-e053-2995a90a9545
Set id: 606d2aea-26c1-44a1-8452-02663b3e51dd
Version: 6
Effective Time: 20220204
 
Sun Bum, LLC