FDA.reportPublic FDA data

Larkly SPF30 Mineral Powder Face Sunscreen

Manufacturer
LARKLY, LLC | Cosco International, Inc.
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:07

Label at a glance#

ProductLarkly SPF30 Mineral Powder Face Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure14 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 children under 6 months: Ask a doctor   

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient...........................Purpose

Titanium Dioxide 21.00%..................Sunscreen

Zinc Oxide 15.00%..........................Sunscreen

Uses

SPL UNCLASSIFIED 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 external use only

OTC - DO NOT USE SECTION

Do not use on damaged or borken 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

INSTRUCTIONS FOR USE 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
  • children under 6 months: Ask a doctor   

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alpha-Tocopherol, Caprylic/Capric Triglyceride, Capryloyl Glycerin, Ceramide I, Ceramide II, Ceramide III, Ethylhexylglycerin, Fumed Silica, Glycyrrhiza Glabra, Green Tea Leaf, Iron Oxide Black, Iron Oxide Red, Iron Oxide Yellow, Kaolin, Magnesium Hydroxide, Maranta Arundinacea Root, Mica, Glyceryl Caprylate, Glycerin, Caprylhydroxamic Acid, Resveratol, Sebacic Acid Copolymer, Tapioca Starch

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free:  1-888-426-4160

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6g brush box label6g brush box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

brush labelbrush label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6g refill box label6g refill box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

refill bottle labelrefill bottle label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79287-0000-22025-01-30C16284748780-12cef2736-68f9-d83d-e063-dadaa90ab31f3d4e1383-369c-4da5-a65b-d170efb6e6fc
79287-0000-42025-01-30C16284748780-12cef2736-68f9-d83d-e063-dadaa90ab31f3d4e1383-369c-4da5-a65b-d170efb6e6fc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79287-0000-1Larkly SPF30 Mineral Powder Face Sunscreen0.006 kg in 1 BOTTLE, WITH APPLICATORPOWDER0.0062
79287-0000-2Larkly SPF30 Mineral Powder Face Sunscreen1 in 1 BOXPOWDER12
79287-0000-3Larkly SPF30 Mineral Powder Face Sunscreen0.006 kg in 1 JARPOWDER0.0062
79287-0000-4Larkly SPF30 Mineral Powder Face Sunscreen1 in 1 BOXPOWDER12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79287-0000LARKLY SPF30 MINERAL POWDER FACE SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [LARKLY, LLC]2Legacy NDC, 4 package rows20230112_3d4e1383-369c-4da5-a65b-d170efb6e6fc.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79287-000079287-0000-1, 79287-0000-2, 79287-0000-3, 79287-0000-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE 2C04977SRJ5IACT
CERAMIDE 34370DF050BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HEXAMETHYLDISILAZANEH36C68P1BHIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
KAOLIN24H4NWX5COIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
MARANTA ARUNDINACEA ROOTFVN346W31AIACT
MICAV8A1AW0880IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
RESVERATROLQ369O8926LIACT
STARCH, TAPIOCA24SC3U704IIACT

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
b1f5ad10-071e-402d-a6b4-8c562bc198443d4e1383-369c-4da5-a65b-d170efb6e6fc2023-01-11WarningsExact identifier
spl id: b1f5ad10-071e-402d-a6b4-8c562bc19844
spl set id: 3d4e1383-369c-4da5-a65b-d170efb6e6fc

Reported adverse events (FAERS/openFDA)#

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