FDA.reportPublic FDA data

NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light

Manufacturer
ALLI LLC | Pure Source, LLC
Effective date
2025-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:23

Label at a glance#

ProductNAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. 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 and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 protecti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • 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 not intended for ingestion.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Adansonia Digitata Oil, Aloe Barbadensis Leaf Extract, Argania Spinosa Kernel Oil, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Caprylyl Methicone, Carbomer, Ceramide NG, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Dimethicone, Dodecane, Ethyl Vanillin, Glycerin, Glyceryl Laurate, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Root Extract, Hippophae Rhamnoides Fruit Oil, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isododecane, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, PEG-60 Hydrogenated Castor Oil, PEG-8, Pentylene Glycol, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Polysorbate 20, Propanediol, Saccharide Isomerate, Sodium Citrate, Sodium Hyaluronate, Tapioca Starch, Titanium Dioxide (CI 77891), Tocopherol, Tridecyl Salicylate, Trimethylsiloxysilicate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum.

Other Information:

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

(888) 322 - 2612

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label - Carton3Label - Carton3Label - Bottle3Label - Bottle3

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73670-609-00NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light1 in 1 BOXLIQUID11
73670-609-00NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light41.4 mL in 1 BOTTLELIQUID41.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73670-609NAELI TINTED MINERAL MOISTURIZER SUNSCREEN SPF 50, LIGHT (ZINC OXIDE) LIQUID [ALLI LLC]1Current NDC, 2 package rows20250523_3cb4459b-1776-414a-b5c4-0ffb9f1df766.zip

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73670-60973670-609-00

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARGAN OIL4V59G5UW9XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CERAMIDE NGC04977SRJ5IACT
CETEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CHAMOMILEFGL3685T2XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
DODECANE11A386X1QHIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ISODODECANEA8289P68Y2IACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PENTYLENE GLYCOL50C1307PZGIACT
PERSEA GRATISSIMA (AVOCADO) OIL6VNO72PFC1IACT
POLYSORBATE 207T1F30V5YHIACT
PROPANEDIOL5965N8W85TIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, LightZINC OXIDEALLI LLC3cb4459b-1776-414a-b5c4-0ffb9f1df7662025-05-22WarningsExact identifier
ndc (package): 73670-609-00
ndc (product): 73670-609
ndc11 (package): 73670060900
spl id: 35b66420-ac52-494b-e063-6294a90a5955
spl set id: 3cb4459b-1776-414a-b5c4-0ffb9f1df766

Reported adverse events (FAERS/openFDA)#

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