FDA.reportPublic FDA data

Exuviance Skin Caring BB Fluid

Manufacturer
NeoStrata Company Inc.
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:06

Label at a glance#

ProductExuviance Skin Caring BB Fluid with Sunscreen Broad Spectrum SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 Sun Protection Measures. Spending time in...

Storage and handling

Store at 15°C-30°C (59°F – 86°F) Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7%
Zinc Oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • Store at 15°C-30°C (59°F – 86°F)
  • Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 50 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58414-0025-12022-03-09C16284748780-1ba0f9c33-3cb4-a910-e053-dadaa90a0b85Exuviance ® Skin Caring BB Fluid with Sunscreen Broad Spectrum SPF 50
58414-0025-12021-01-29C16284748780-1ba0f9c33-3cb4-a910-e053-dadaa90a0b85Exuviance ® Skin Caring BB Fluid with Sunscreen Broad Spectrum SPF 50

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58414-0025EXUVIANCE SKIN CARING BB FLUID WITH SUNSCREEN BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [NEOSTRATA COMPANY INC.]4Legacy NDC20250112_4d644872-7a55-4e66-a191-39632451d877.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58414-002558414-0025-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
HYDROGENATED POLYDECENE TYPE IU333RI6EB7IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLUCONOLACTONEWQ29KQ9POTIACT
ALUMINUM OXIDELMI26O6933IACT
AMMONIA5138Q19F1XIACT
LACTOBIONIC ACID65R938S4DVIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PHENETHYL BENZOATE0C143929GKIACT
NYLON-12446U8J075BIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EPIGALLOCATECHIN GALLATEBQM438CTELIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOHEXADECANE918X1OUF1EIACT
TOCOPHEROLR0ZB2556P8IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
DIPROPYLENE GLYCOLE107L85C40IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PROPYLENE CARBONATE8D08K3S51EIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM BISULFITETZX5469Z6IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
42c21b94-84ec-f47c-e063-6294a90a02874d644872-7a55-4e66-a191-39632451d8772025-11-04WarningsExact identifier
spl set id: 4d644872-7a55-4e66-a191-39632451d877

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.