FDA.reportPublic FDA data

NATURIUM Dew-Glow Moisturizer SPF 50

Manufacturer
PML NYC, LLC
Effective date
2026-04-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:53:44

Label at a glance#

ProductNATURIUM Dew-Glow Moisturizer SPF 50
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE
Label structure11 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 at least every 2 hours, Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: li...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

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. Do not use on damaged or broken skin. Stop use and ask doctor if rash occurs.

Warnings-When using

OTC - WHEN USING SECTION

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

Keep out of reach of children

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 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours, Children under 6 months: ask a doctor.
Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early aging. To decrease
this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun especially from 10:00 a.m. - 2:00 p.m. Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Glycerin, Glyceryl Stearate, Ethylhexyl Methoxycrylene, VP/Eicosene Copolymer, Stearyl Dimethicone, Argania Spinosa Kernel Oil, Tocopheryl Acetate, 1,2-Hexanediol, Niacinamide, Tocopherol, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Sodium Stearoyl Glutamate, Octadecene, Sorbitan Olivate, Xanthan Gum, Bisabolol, 3-o-ethyl ascorbic acid, Sodium Hyaluronate, Squalane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide, Sorbitan Oleate, Caprylyl/Capryl Glucoside.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

RECENT MAJOR CHANGES SECTION

DOSAGE & ADMINISTRATION

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59735-338-012026-01-29C16284748780-149896155-b57c-586f-e063-e6dba90add90NATURIUM Dew-Glow Moisturizer SPF 50
59735-338-042026-01-29C16284748780-149896155-b57c-586f-e063-e6dba90add90NATURIUM Dew-Glow Moisturizer SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-338-01NATURIUM Dew-Glow Moisturizer SPF 501 in 1 CARTONCREAM14
59735-338-01NATURIUM Dew-Glow Moisturizer SPF 5050 mL in 1 TUBECREAM504
59735-338-03NATURIUM Dew-Glow Moisturizer SPF 5050 mL in 1 TUBECREAM504
59735-338-04NATURIUM Dew-Glow Moisturizer SPF 501 in 1 CARTONCREAM14

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-33859735-338-01, 59735-338-03, 59735-338-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
EICOSYL POVIDONEXQQ9MKE2BJIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
CETEARYL OLIVATE58B69Q84JOIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYISOBUTYLENE (65000 MW)VC9JLP352JIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
SORBITAN OLIVATEMDL271E3GRIACT
ARGAN OIL4V59G5UW9XIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
SQUALANEGW89575KF9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
OCTADECENEH5ZUQ6V4AKIACT
XANTHAN GUMTTV12P4NEEIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
3-O-ETHYL ASCORBIC ACID6MW60CB71PIACT
HYALURONATE SODIUMYSE9PPT4THIACT
NIACINAMIDE25X51I8RD4IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT

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
NATURIUM Dew-Glow Moisturizer SPF 50NATURIUM DEW-GLOW MOISTURIZER SPF 50PML NYC, LLC00c93b11-754e-701c-e063-6294a90a3b1d2026-04-14WarningsExact identifier
ndc (package): 59735-338-04
ndc (package): 59735-338-03
ndc (package): 59735-338-01
ndc (product): 59735-338
ndc11 (package): 59735033801
ndc11 (package): 59735033804
ndc11 (package): 59735033803
spl id: 4f7828b7-bf2d-e4e7-e063-6294a90a3e0f
spl set id: 00c93b11-754e-701c-e063-6294a90a3b1d

Reported adverse events (FAERS/openFDA)#

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