FDA.reportPublic FDA data

Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc Oxide

Manufacturer
Lucin Organics, LLC
Effective date
2024-03-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:22

Label at a glance#

ProductLucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc Oxide
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

helps prevent sunburn

Dosage and administration

 • apply liberally 15 minutes before sun exposure. • children under 6 months of age: Ask a doctor  • 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-Nano) 14%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

• 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

OTC - STOP USE SECTION

if rash occurs.

• 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. • children under 6 months of age: Ask a doctor  • 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 value 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 • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Distilled Water), Organic Olive Squalane, Shea Butter Ethyl Esters, Simmondsia Chinensis (Jojoba) Esters, Organic Vitis Vinifera (Grape) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Polyglyceryl-4 Olivate/Polyricinoleate, Lactobacillus Ferment, Sorbitan Olivate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Magnesium Sulfate, Organic Rosmarinus Officinalis (Rosemary) Leaf Extract, Organic Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil, Cananga Odorata (Ylang Ylang) Oil, Pelargonium Graveolens (Geranium) Oil. May Contain (±): CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide). Citronellol**, Geraniol**, Linalool**

*Cerified Oraganic Ingredients

** Components of 100% pure essential oils

Other information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

info@lucinorganics.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

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
84124-000-00Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc Oxide1 in 1 PACKAGECREAM13
84124-000-00Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc Oxide50 mL in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84124-000LUCIN ORGANICS TINTED SUNSCREEN SPF 30 NON NANO ZINC OXIDE (ZINC OXIDE) CREAM [LUCIN ORGANICS, LLC]3Current NDC, 2 package rows20240305_d717dda8-60bb-40a0-86f9-6d724d695d16.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84124-00084124-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT
GRAPE6X543N684KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYGLYCERYL-4 OLIVATE/POLYRICINOLEATEWYX2KZL5BDIACT
SORBITAN OLIVATEMDL271E3GRIACT
BIFIDOBACTERIUM ANIMALIS LACTIS5307V7XW8IIACT
COCONUT3RT3536DHYIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ROSEMARYIJ67X351P9IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
LAVENDER OILZBP1YXW0H8IACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
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
Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc OxideZINC OXIDELucin Organics, LLCd717dda8-60bb-40a0-86f9-6d724d695d162024-03-04WarningsExact identifier
ndc (package): 84124-000-00
ndc (product): 84124-000
ndc11 (package): 84124000000
spl id: 12d918f1-2f30-26f3-e063-6394a90aded2
spl set id: d717dda8-60bb-40a0-86f9-6d724d695d16

Reported adverse events (FAERS/openFDA)#

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