FDA.reportPublic FDA data

NeoStrata

Manufacturer
NeoStrata Company Inc.
Effective date
2026-08-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-28 00:02:09

Label at a glance#

ProductNeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum 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 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply sunscreen 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, especia...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply sunscreen 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/Eau, Acetyl Glucosamine, Butyloctyl Salicylate, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Cyclohexasiloxane, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Extract, Tetrahydrodiferuloylmethane, 4-Butyl-resorcinol, Ceteth-20, PEG-75 Stearate, Propylene Glycol, Disodium EDTA, Steareth-20, Xanthan Gum, Ammonium Hydroxide, Sodium Bisulfite, Carbomer, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin.

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

1-800-628-9904

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEOSTRATA ®
ENLIGHTEN
UNEVEN TONE AND
DARK SPOTS
Skin Brightener
with Sunscreen Broad
Spectrum SPF 35
NET WT
40 g / 1.4 OZ

NeostrataNeostrata

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130732013301316GTIN-13: 0732013301316
EAN-13: 0732013301316
GTIN-12: 732013301316
UPC-A: 732013301316
GTIN storage (14 digits): 00732013301316		Neostarta-1.jpg
Data codeData Matrix29F30131XBNeostarta-1.jpg
Data codeITF01001057Neostarta-1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58414-0019-12022-03-08C16284748780-19d75b9d0-d5d0-f424-e053-dadaa90a57ceNeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35
58414-0019-12022-03-08C16284748780-19d75b9d0-d5d0-f424-e053-dadaa90a57ceNeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35
58414-0019-12020-01-31C16284748780-19d75b9d0-d5d0-f424-e053-dadaa90a57ceNeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35
58414-0019-12020-01-31C16284748780-19d75b9d0-d5d0-f424-e053-dadaa90a57ceNeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58414-001958414-0019-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
N-ACETYLGLUCOSAMINEV956696549IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE92RU3N3Y1OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CYCLOMETHICONE 6XHK3U310BAIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
4-BUTYLRESORCINOL2IK4UQ3ZGAIACT
TETRAHYDRODIFERULOYLMETHANE00U0645U03IACT
PEG-75 STEARATEOT38R0N74HIACT
STEARETH-20L0Q8IK9E08IACT
CETETH-20I835H2IHHXIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BISULFITETZX5469Z6IIACT
AMMONIA5138Q19F1XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-01-10full-release2026-06-01 00:52:24

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
NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.ed495f18-2f8e-4991-b797-82e9f6fc7acb2026-08-25WarningsExact identifier
ndc (package): 58414-0019-1
ndc (product): 58414-0019
ndc11 (package): 58414001901
spl id: 59e15d1b-73fa-37e9-e063-6394a90a5d62
spl set id: ed495f18-2f8e-4991-b797-82e9f6fc7acb

Reported adverse events (FAERS/openFDA)#

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