Label: SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion
- NDC Code(s): 69039-623-01, 69039-623-02
- 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
- Warnings
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Directions
- shake well before use
- 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 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, 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?
- Package Labeling:
- Package Labeling:69039-623-02
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INGREDIENTS AND APPEARANCE
SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-623 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-623-01 88 mL in 1 TUBE; Type 0: Not a Combination Product 02/22/2021 2 NDC:69039-623-02 30 mL in 1 TUBE; Type 0: Not a Combination Product 09/01/2021 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)
