Label: EXUVIANCE SKIN CARING BB FLUID WITH SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide lotion
- NDC Code(s): 58414-0025-1
- Packager: NeoStrata Company Inc.
- 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 September 1, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- With first use or after a period of non-use, shake vigorously for at least 1 minute to achieve a uniform consistency. During periods of regular use, shake vigorously for at least 15 seconds before use. Apply liberally to face, neck and other exposed areas, 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
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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 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-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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Inactive ingredients
Water, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Polydecene, Butyloctyl Salicylate, Gluconolactone, Styrene/Acrylates Copolymer, Alumina, Ammonium Hydroxide, Lactobionic Acid, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenethyl Benzoate, Nylon-12, Tocopheryl Acetate, Epigallocatechin Gallate, Polyhydroxystearic Acid, Ethylhexylglycerin, Tocopherol, Dimethicone/PEG-10/15 Crosspolymer, Hydrogen Dimethicone, Isohexadecane, Sodium Citrate, Disteardimonium Hectorite, Magnesium Sulfate, Dipropylene Glycol, Propylene Carbonate, Sodium Bisulfite, Triethoxycaprylylsilane, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
- Other information
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- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
EXUVIANCE SKIN CARING BB FLUID WITH SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58414-0025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 70 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLUCONOLACTONE (UNII: WQ29KQ9POT) ALUMINUM OXIDE (UNII: LMI26O6933) AMMONIA (UNII: 5138Q19F1X) LACTOBIONIC ACID (UNII: 65R938S4DV) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) PHENETHYL BENZOATE (UNII: 0C143929GK) NYLON-12 (UNII: 446U8J075B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOHEXADECANE (UNII: 918X1OUF1E) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) DIPROPYLENE GLYCOL (UNII: E107L85C40) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM BISULFITE (UNII: TZX5469Z6I) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58414-0025-1 1 in 1 CARTON 10/01/2019 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2019 Labeler - NeoStrata Company Inc. (605754829)
