EXUVIANCE SKIN CARING BB FLUID  WITH SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide lotion 
NeoStrata Company Inc.

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.

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Exuviance® Skin Caring BB Fluid
with Sunscreen Broad Spectrum SPF 50

Drug Facts

Active ingredients

Titanium Dioxide 7%
Zinc Oxide 6%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Questions or comments?

Call toll-free 1-800-225-9411 (9am – 5pm ET)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

exuviance ®

EMPOWER

SKIN CARING BB FLUID
WITH SUNSCREEN
BROAD SPECTRUM SPF 50 PA++++

Lightly hydrate,
even tone
Protect against
environmental
exposure
Universal tint
PHA/Bionic
Mineral Sunscreen
Green Tea

50 mL/1.7 fl oz

Principal Display Panel - 50 mL Bottle Carton
EXUVIANCE SKIN CARING BB FLUID   WITH SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-0025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58414-0025-11 in 1 CARTON10/01/2019
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2019
Labeler - NeoStrata Company Inc. (605754829)

Revised: 9/2023
Document Id: 86cc7e4a-300e-4f6b-ae14-9a99ce9622b3
Set id: 4d644872-7a55-4e66-a191-39632451d877
Version: 3
Effective Time: 20230901
 
NeoStrata Company Inc.