Label: SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide liquid
- NDC Code(s): 69039-624-01
- 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 ingredient
- Uses
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Warnings
- For external use only
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Directions
- shake well before use
- hold container 4 to6 inches from the skin to apply
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- do not spray directly into face. Spray on hands then apply to face
- do not apply in windy conditions
- use in well-ventilated area
- 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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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
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Inactive ingredients
water, butyloctyl salicylat, helianthus annus (sunflower) seed oil, dicaprylyl carbonate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, polyester-8, sodium stearoyl glutamate, coco-glucoside, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, tocopherol, glycerin, cellulose gum,bentonite, microcrystalline cellulose, caprylyl glycol, silica, polyhydroxystearic acid, citric acid, alumina, bisabolol, sodium gluconate, caprylhydroxamic acid
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-624 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 34 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 160 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SUNFLOWER OIL (UNII: 3W1JG795YI) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PROPANEDIOL (UNII: 5965N8W85T) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) COCO GLUCOSIDE (UNII: ICS790225B) ALOE VERA LEAF (UNII: ZY81Z83H0X) BANANA (UNII: 4AJZ4765R9) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) BENTONITE (UNII: A3N5ZCN45C) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALUMINUM OXIDE (UNII: LMI26O6933) LEVOMENOL (UNII: 24WE03BX2T) SODIUM GLUCONATE (UNII: R6Q3791S76) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-624-01 170 g in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/22/2021 Labeler - Sun Bum LLC (028642574)
