Label: BIOSOLIS FACE SUNSCREEN BROADSPECTRUM SPF50- titanium dioxide, zinc oxide cream
- NDC Code(s): 61296-017-00
- 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
ALOE VERA LEAF JUICE*, ALUMINUM HYDROXIDE,BENZYL ALCOHOL, BISABOLOL*,CAPRYLIC/CAPRIC TRIGLYCERIDE,DEHYDROACETIC ACID, DICAPRYLYL CARBONATE,GLYCERYL BEHENATE, GLYCERYL DIBEHENATE,KARANJA TREE SEED EXTRACT, POLYGLYCERYL-2DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3DIISOSTEARATE, POLYHYDROXYSTEARIC ACID,PROPANEDIOL, SESAME OIL*, SODIUM CHLORIDE,STEARIC ACID, TOCOPHEROL, TRIBEHENIN, WATER.
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- Package Labeling:61296-017-00
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INGREDIENTS AND APPEARANCE
BIOSOLIS FACE SUNSCREEN BROADSPECTRUM SPF50
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61296-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 100 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 152 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BENZYL ALCOHOL (UNII: LKG8494WBH) LEVOMENOL (UNII: 24WE03BX2T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DEHYDROACETIC ACID (UNII: 2KAG279R6R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) PONGAMIA PINNATA SEED (UNII: C2BRV53B1V) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) SESAME OIL (UNII: QX10HYY4QV) SODIUM CHLORIDE (UNII: 451W47IQ8X) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) TRIBEHENIN (UNII: 8OC9U7TQZ0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61296-017-00 1 in 1 BOX 01/07/2022 12/31/2024 1 50 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 12/31/2024 Labeler - Pro Vera SA (375713286) Registrant - Pro Vera SA (375713286)