Label: BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50- titanium dioxide, zinc oxide cream
- NDC Code(s): 61296-016-00
- Packager: Pro Vera SA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 10, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- 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 aBroad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 3 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- reapply
- after swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
ALUMINUM HYDROXIDE, BISABOLOL*,CAPRYLIC/CAPRIC TRIGLYCERIDE, COCONUT OIL*, DICAPRYLYL CARBONATE, FRAGANCE,HYDROGENATED COCONUT OIL**, KARANJATREE SEED EXTRACT, LIMONENE, LINALOOL,POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,POLYGLYCERYL-3 DIISOSTEARATE ,POLYHYDROXYSTEARIC ACID, PROPANEDIOL,SESAME OIL*, STEARIC ACID, TOCOPHEROL,WATER.
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- Package Labeling:61296-016-00
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INGREDIENTS AND APPEARANCE
BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61296-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 108 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 142 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) LEVOMENOL (UNII: 24WE03BX2T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) PONGAMIA PINNATA SEED (UNII: C2BRV53B1V) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) SESAME OIL (UNII: QX10HYY4QV) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61296-016-00 1 in 1 BOX 01/07/2022 03/31/2025 1 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/07/2022 03/31/2025 Labeler - Pro Vera SA (375713286) Registrant - Pro Vera SA (375713286)