Label: SUN BUM MINERAL SUNSCREEN ROLL ON SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 69039-641-01
- 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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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
• shake well before use • apply liberally and spread by hand15 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 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 salicylate, dicaprylyl carbonate, isononyl isononanoate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, bisabolol, bentonite, cellulose gum, C18-21 alkane, caprylyl glycol, citric acid, coco-glucoside, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodium stearoyl glutamate, tocopherol, polyester-8, silica, alumina, caprylhydroxamic acid
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INGREDIENTS AND APPEARANCE
SUN BUM MINERAL SUNSCREEN ROLL ON SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-641 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 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 160 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) PROPANEDIOL (UNII: 5965N8W85T) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALOE VERA LEAF (UNII: ZY81Z83H0X) BANANA (UNII: 4AJZ4765R9) LEVOMENOL (UNII: 24WE03BX2T) BENTONITE (UNII: A3N5ZCN45C) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) C18-C21 ALKANE (UNII: 33822S0M40) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO GLUCOSIDE (UNII: ICS790225B) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM GLUCONATE (UNII: R6Q3791S76) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) TOCOPHEROL (UNII: R0ZB2556P8) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-641-01 88 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2022 Labeler - Sun Bum LLC (028642574)