Label: BABY BUM SPF50 MINERAL SUNSCREEN- zinc oxide cream
- NDC Code(s): 69039-255-00, 69039-255-01
- Packager: Sun Bum, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 4, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
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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
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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?
- Package Labeling:
- Package Labeling:69039-255-01
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INGREDIENTS AND APPEARANCE
BABY BUM SPF50 MINERAL SUNSCREEN
zinc oxide creamProduct 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 2 NDC:69039-255-01 15 mL in 1 PACKET; Type 0: Not a Combination Product 03/12/2021 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)
