FDA.reportPublic FDA data

Naturalessa SPF50 Moisturizer

Manufacturer
Audrey Morris Cosmetics International, LLC
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:47:54

Label at a glance#

ProductNaturalessa SPF50 Moisturizer
Active ingredientZINC OXIDE
Label structure8 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 aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying. 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 broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, ...

Label contents#

Full prescribing information#

Active Ingredients                          Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22.3% W/W                    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 aging caused by the sun.

Warnings

WARNINGS SECTION

For Extranal use only
Do not use on damaged or broken skin.
When using this product

  • Keep out of eyes. Rinse with water to remove

Stop use and ask doctor

  • Rash or irritation develops and lasts

Keep out of reach if children

  • If product gets swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying.
  • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00a.m – 2:00p.m
  • Wear long sleave shirts, pants, hats, and sunglasses.
  • Children under 6 Months: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direact sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice, Coco-Caprylate/Caprate, Butyl Salicylate, Isoamyl Laurate, Glycerin, Shea (Butyrospermum Parkii) Butter, Jojoba (Simmondsia Chinensis) Seed Oil, Propanediol, Tridecyl Salicylate, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, Green Tea (Camellia Sinensis) Leaf Extract, Sphingomonas Ferment Extract, Pongamia Pinnata Seed Extract, Xanthan Gum, Cetyl Alcohol, Silica, Lecithin, Sclerotium Gum, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Pullulan, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

Questions or Comments?

SPL UNCLASSIFIED SECTION

1-800-826-8287

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83695-003-01Naturalessa SPF50 Moisturizer113 g in 1 BOTTLECREAM1131
83695-003-01Naturalessa SPF50 Moisturizer1 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83695-00383695-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
BUTYL SALICYLATEQPR9LM8VZOIACT
ISOAMYL LAURATEM1SLX00M3MIACT
GLYCERINPDC6A3C0OXIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
PROPANEDIOL5965N8W85TIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
BEHENIC ACIDH390488X0AIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
XANTHAN GUMTTV12P4NEEIACT
CETYL ALCOHOL936JST6JCNIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SOYBEAN LECITHIN1DI56QDM62IACT
BETASIZOFIRAN2X51AD1X3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PULLULAN8ZQ0AYU1TTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERMENT COMPLEX 6/PFRH73PR9HMAIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Naturalessa SPF50 MoisturizerZINC OXIDEAudrey Morris Cosmetics International, LLC816ddfa1-cb55-4591-a90b-71631cb176262026-02-26WarningsExact identifier
ndc (package): 83695-003-01
ndc (product): 83695-003
ndc11 (package): 83695000301
spl id: 4bbf9ba3-ef70-5bf7-e063-6394a90a28fb
spl set id: 816ddfa1-cb55-4591-a90b-71631cb17626

Reported adverse events (FAERS/openFDA)#

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