SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion 
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 Sunscreen Lotion Broad Spectrum SPF 50

Drug Facts

Active ingredient

Zinc oxide 20%

Purpose

Sunscreen

Uses

Warnings

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

protect this product from excessive heat and direct sun.

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, arachidyl alcohol, coco glucoside, tocopherol, theobroma cacao (cocoa) seed butter, cetyl alcohol, behenyl alcohol, bisabolol, arachidyl glucoside, microcrystalline cellulose, cellulose gum, sodium hyaluronate, sodium gluconate, phenoxyethanol, citric acid, ethylhexylglycerin, polyhydroxystearic acid

Questions?

1-877-978-6286

Package Labeling:

Label4

Package Labeling:69039-623-02

Tube

SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-623
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)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
COCO GLUCOSIDE (UNII: ICS790225B)  
TOCOPHEROL (UNII: R0ZB2556P8)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DOCOSANOL (UNII: 9G1OE216XY)  
LEVOMENOL (UNII: 24WE03BX2T)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-623-0188 mL in 1 TUBE; Type 0: Not a Combination Product02/22/2021
2NDC:69039-623-0230 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/22/2021
Labeler - Sun Bum LLC (028642574)

Revised: 2/2022
Document Id: d72eed5b-3a59-08db-e053-2995a90a9668
Set id: bcd0d483-f506-4c7c-e053-2995a90a5733
Version: 3
Effective Time: 20220204
 
Sun Bum LLC