FDA.reportPublic FDA data

Clean Tinted Lotion

Manufacturer
Clean, Know What's On Your Skin LLC
Effective date
2019-03-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:01

Label at a glance#

ProductClean Tinted
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 skin 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 two hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product:

OTC - WHEN USING SECTION

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

Stop use and ask doctor

OTC - STOP USE SECTION

is skin rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is 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 two hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: ask a Doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C16 Alpha Olefin, Capryl Glycol, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract*, Citrus Aurantium Dulcis (Orange) Fruit Extract*, Citrus Aurantium Dulcis (Orange) Peel Extract*, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Seed Oil*, Glycerin*,Hexylene Glycol, Iron Oxides, Isododecane, Oenothera Biennis (Evening Primrose) Oil*, Palmaria Palmata Extract, Phenoxyethanol, Propanediol, Rosa Canina Fruit Oil*, Sodium Chloride, Tetrasodium Glutamate Diacetate, Tocopherol, Triethoxycaprylylsilane, Trilaureth-4 Phosphate, VP/ Eicosene Copolymer, Water, Zostera Marina Extract *=Organic

Other information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 424-272-6522

Clean Tinted Lotion, 50mL (72394-000-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelTubeTubeBoxBox

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
72394-001-002021-01-29C16284748780-1ba0f9c33-2605-a910-e053-dadaa90a0b85Clean Tinted Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72394-001-00Clean Tinted50 mL in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72394-001CLEAN TINTED (ZINC OXIDE) LOTION [CLEAN, KNOW WHAT'S ON YOUR SKIN LLC]2Legacy NDC, 1 package rows20190330_6f04e9e1-f592-997d-e053-2a91aa0a81eb.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72394-00172394-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBYL PALMITATEQN83US2B0NIACT
LEVOMENOL24WE03BX2TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CHAMOMILEFGL3685T2XIACT
ORANGE5EVU04N5QUIACT
ORANGE PEELTI9T76XD44IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
FERRIC OXIDE RED1K09F3G675IACT
ISODODECANEA8289P68Y2IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
DULSE7832HOY4ZQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPANEDIOL5965N8W85TIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
WATER059QF0KO0RIACT
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
853ecad3-ad50-32fe-e053-2991aa0ab96e6f04e9e1-f592-997d-e053-2a91aa0a81eb2019-03-29WarningsExact identifier
spl id: 853ecad3-ad50-32fe-e053-2991aa0ab96e
spl set id: 6f04e9e1-f592-997d-e053-2a91aa0a81eb

Reported adverse events (FAERS/openFDA)#

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