FDA.reportPublic FDA data

Exuviance Sheer Refining Fluid SPF 35

Manufacturer
NeoStrata Company Inc. | Cosmetic Essence, LLC
Effective date
2018-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:53:25

Label at a glance#

ProductExuviance Sheer Refining Fluid SPF 35
Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE
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

Apply liberally to face and neck daily, 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 th...

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

Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%
Ethylhexyl Salicylate (Octisalate) 5.0%
Butyl Methoxydibenzoylmethane (Avobenzone) 3.0%

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 use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if 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

  • Apply liberally to face and neck daily, 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

Aqua (Water), Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, Glycerin, C12-C15 Alkyl Benzoate, Dimethicone, Butylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Tocopheryl (Vitamin E) Acetate, Melia Azadirachta Leaf Extract, Arctium Lappa Root Extract, Vitis Vinifera (Grape) Seed Extract, Lecithin, Dimethicone Crosspolymer, Propylene Glycol, PEG-75 Stearate, Xanthan Gum, Disodium EDTA, Ceteth-20, Steareth-20, Carbomer, Ammonium Hydroxide, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Sodium Bisulfite

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

DERMATOLOGIST DEVELOPED
Exuviance®

Sheer Refining Fluid

oily / acne prone

with Sunscreen
Broad Spectrum SPF 35

Powerful antiaging benefits
for oily skin

Formulated to firm, smooth fine
lines and even skin tone

Controls oiliness

50 mL / 1.75 fl oz

Principal Display Panel - 50 mL Bottle Carton
Principal Display Panel - 50 mL Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
AMMONIAINACTIVE INGREDIENT5138Q19F1X1
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z31
AZADIRACHTA INDICA LEAFINACTIVE INGREDIENTHKY915780T1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D31
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO1
CETETH-20INACTIVE INGREDIENTI835H2IHHX1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OK1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N1
N-ACETYLGLUCOSAMINEINACTIVE INGREDIENTV9566965491
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883T1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PEG-75 STEARATEINACTIVE INGREDIENTOT38R0N74H1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6I1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E081
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

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
58414-204758414-2047-1

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
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
N-ACETYLGLUCOSAMINEV956696549IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-75 STEARATEOT38R0N74HIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
CETETH-20I835H2IHHXIACT
STEARETH-20L0Q8IK9E08IACT
AMMONIA5138Q19F1XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM BISULFITETZX5469Z6IIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERRSA9I561OKIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 388 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XFILM / SUBLINGUALNAExact identifier — unii candidate
14 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM BISULFITESODIUM BISULFITETZX5469Z6IINJECTION / IRRIGATION0.66 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BISULFITESODIUM BISULFITETZX5469Z6IINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XSOLUTION / OPHTHALMICADJ PHExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BISULFITESODIUM BISULFITETZX5469Z6IINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BISULFITESODIUM BISULFITETZX5469Z6IINJECTION / INTRASYNOVIAL0.32 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
14 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XCREAM / TOPICAL5.72 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / VAGINAL140 mgExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BISULFITESODIUM BISULFITETZX5469Z6IINJECTION / SUBCUTANEOUS0.22 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BISULFITESODIUM BISULFITETZX5469Z6IINJECTION / INTRA-ARTICULAR0.32 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
dddd25fe-827d-45e0-bad0-65017f44bb8803ccf625-9cd6-49af-b10b-b4f3360539102018-07-16WarningsExact identifier
spl id: dddd25fe-827d-45e0-bad0-65017f44bb88
spl set id: 03ccf625-9cd6-49af-b10b-b4f336053910

Reported adverse events (FAERS/openFDA)#

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