FDA.reportPublic FDA data

Exuviance Essential Daily Defense SPF 30

Manufacturer
NeoStrata Company Inc. | Cosmetic Essence, LLC.
Effective date
2018-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:58:16

Label at a glance#

ProductExuviance Essential Daily Defense SPF 30
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
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) 6.0%
Titanium Dioxide 4.0%

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), Glycolic Acid, C12-15 Alkyl Benzoate, Isocetyl Stearate, Glycerin, Glyceryl Stearate, Octyldodecyl Neopentanoate, Hydrogenated Polydecene, PEG-100 Stearate, Ammonium Hydroxide, Citric Acid, Dimethicone, Propylene Glycol, Lactobionic Acid, Cetearyl Alcohol, Methicone, Tocopheryl (Vitamin E) Acetate, Rosa Centifolia Flower Extract, Sambucus Nigra Flower Extract, Vitis Vinifera (Grape) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Arginine, Calendula Officinalis Flower Extract, Palmitic Acid, Stearic Acid, Myristic Acid, Hydroxyethylcellulose, Disodium EDTA, Xanthan Gum, Alumina, Polyhydroxystearic Acid, Polysorbate 20, Phenoxyethanol, Chlorphenesin

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 g Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMATOLOGIST DEVELOPED
Exuviance ®

Essential Daily
Defense Creme

normal / combination

with Sunscreen
Broad Spectrum SPF 20

Antiaging complex reduces lines,
stimulates cell renewal

AHA/Bionic blend plus antioxidants
for added defense

Net Wt 50 g / 1.75 oz

Principal Display Panel - 50 g Bottle Carton
Principal Display Panel - 50 g Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
AMMONIAINACTIVE INGREDIENT5138Q19F1X1
ARGININEINACTIVE INGREDIENT94ZLA3W45F1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38S1
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB71
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EP1
ISOCETYL STEARATEINACTIVE INGREDIENT3RJ7186O9W1
LACTOBIONIC ACIDINACTIVE INGREDIENT65R938S4DV1
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKT1
MYRISTIC ACIDINACTIVE INGREDIENT0I3V7S25AW1
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883T1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H11
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
ROSA CENTIFOLIA FLOWERINACTIVE INGREDIENTCS4TE8FF7O1
SAMBUCUS NIGRA FLOWERINACTIVE INGREDIENT07V4DX094T1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
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 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58414-204658414-2046-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
GLYCOLIC ACID0WT12SX38SIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOCETYL STEARATE3RJ7186O9WIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
PEG-100 STEARATEYD01N1999RIACT
AMMONIA5138Q19F1XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LACTOBIONIC ACID65R938S4DVIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHICONE (20 CST)6777U11MKTIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ROSA CENTIFOLIA FLOWERCS4TE8FF7OIACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
CHAMOMILEFGL3685T2XIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ARGININE94ZLA3W45FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
MYRISTIC ACID0I3V7S25AWIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
EDETATE DISODIUM7FLD91C86KIACT
XANTHAN GUMTTV12P4NEEIACT
ALUMINUM OXIDELMI26O6933IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT

Source Document#

Source XML · Source PDF

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 8 · 480 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XTABLET / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / RECTAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EXTENDED RELEASE / ORAL45 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XCAPSULE / ORAL0.01 mgExact identifier — unii candidate
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
14 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XINJECTION / INTRAVENOUS0.22 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 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
e2290068-17c4-4797-bc8d-576c0777f59379b3ede1-b1ec-4a15-b519-3302c09aee392018-05-15WarningsExact identifier
spl id: e2290068-17c4-4797-bc8d-576c0777f593
spl set id: 79b3ede1-b1ec-4a15-b519-3302c09aee39

Reported adverse events (FAERS/openFDA)#

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