Label: BRUSH ON BLOCK SHEER GENIUS BROAD SPECTRUM SPF 50- zinc oxide 12% lotion
- NDC Code(s): 58274-010-01
- Packager: SPF Ventures, 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 January 20, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- Reapply: • at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- 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 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Tryglyceride, Caprylyl Glycol, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexyylene Glycol, Isoamyl Laurate, Jojoba Esters, Lecithin, Lysolecithin, Methylpropanediol, PEG-75 Stearate, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Pullulan, Pyrus Malus (Apple) Fruite Extract, Sclerotium Gum. Silica, Sodium Hydroxide, Squalene, Steareth-20, Tetrasodium Glutamate Diacetate, Tocopherol, Water, Xanthan Gum.
- Other Information
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INGREDIENTS AND APPEARANCE
BRUSH ON BLOCK SHEER GENIUS BROAD SPECTRUM SPF 50
zinc oxide 12% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58274-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12 g in 100 mL Inactive Ingredients Ingredient Name Strength HEXYLENE GLYCOL (UNII: KEH0A3F75J) ISOAMYL LAURATE (UNII: M1SLX00M3M) METHYLPROPANEDIOL (UNII: N8F53B3R4R) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) APPLE (UNII: B423VGH5S9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETETH-20 (UNII: I835H2IHHX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PEG-75 STEARATE (UNII: OT38R0N74H) BETASIZOFIRAN (UNII: 2X51AD1X3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) LEVOMENOL (UNII: 24WE03BX2T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) PULLULAN (UNII: 8ZQ0AYU1TT) WATER (UNII: 059QF0KO0R) TOCOPHEROL (UNII: R0ZB2556P8) ALLANTOIN (UNII: 344S277G0Z) STEARETH-20 (UNII: L0Q8IK9E08) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SQUALANE (UNII: GW89575KF9) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHENYLPROPANOL (UNII: 0F897O3O4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58274-010-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/13/2022 Labeler - SPF Ventures, LLC (055483891)
