Label: SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion
- NDC Code(s): 69039-622-01, 69039-622-02
- 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, capryloyl glycerin/sebacic acid copolymer, methyl dihydroabietate, butyrospermum parkii (shea butter), cetearyl alcohol, sodium stearoyl glutamate, theobroma cacao (cocoa) seed butter, tocopherol, coco glucoside, microcrystalline cellulose, cetyl alcohol, behenyl alcohol, bisabolol, arachidyl glucoside, phenoxyethanol, arachidyl alcohol, cellulose gum, sodium hyaluronate, sodium gluconate, citric acid, ethylhexylglycerin, polyhydroxystearic acid
- Questions?
- Package Labeling:
- Package Labeling:69039-622-02
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INGREDIENTS AND APPEARANCE
SUN BUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 147 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCONUT OIL (UNII: Q9L0O73W7L) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) SHEA BUTTER (UNII: K49155WL9Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) COCOA BUTTER (UNII: 512OYT1CRR) TOCOPHEROL (UNII: R0ZB2556P8) COCO GLUCOSIDE (UNII: ICS790225B) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CETYL ALCOHOL (UNII: 936JST6JCN) DOCOSANOL (UNII: 9G1OE216XY) LEVOMENOL (UNII: 24WE03BX2T) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) PHENOXYETHANOL (UNII: HIE492ZZ3T) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM GLUCONATE (UNII: R6Q3791S76) 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:69039-622-01 88 mL in 1 TUBE; Type 0: Not a Combination Product 02/22/2021 2 NDC:69039-622-02 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 02/22/2021 Labeler - Sun Bum LLC (028642574)
