FDA.reportPublic FDA data

All Calm Clinical Redness Corrector SPF 50

Manufacturer
Colorescience
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:31

Label at a glance#

ProductAll Calm Clinical Redness Corrector SPF 50
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure10 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. Works best on moisturized skin. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months: 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 o...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 11.6%Sunscreen
Zinc Oxide 8.6%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.

OTC - DO NOT USE SECTION

Do not use on damaged or broken 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Caprylic/Capric Triglyceride, Water/Aqua/Eau, Dimethicone Crosspolymer, Niacinamide, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, Disodium Lauriminodipropionate Tocopheryl Phosphates, Crithmum Maritimum Extract, Magnolia Officinalis Bark Extract, Zingiber Officinale (Ginger) Root Extract, Magnesium Carboxymethyl Beta-Glucan, Jojoba Esters, Bisabolol, Silica, Polyhydroxystearic Acid, Dimethiconol, Alumina, Glyceryl Behenate/Eicosadioate, Phenoxyethanol, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Dehydroacetic Acid, Benzoic Acid, Glycolic Acid, Chloroacetic Acid, Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491, CI 77492, CI 77499).

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 866.426.5673

SPL UNCLASSIFIED SECTION

Dist. in USA by
colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

ALL CALM™

CLINICAL REDNESS
CORRECTOR

Instantly neutralizes redness
Soothes sensitive skin

50
Broad Spectrum
SPF 50 Sunscreen
PA++++

1 fl. oz. / 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68078-023-022021-10-05C16284748780-1ba0f9c33-4c46-a910-e053-dadaa90a0b85All Calm™ Clinical Redness Corrector SPF 50
68078-023-242021-10-05C16284748780-1ba0f9c33-4c46-a910-e053-dadaa90a0b85All Calm™ Clinical Redness Corrector SPF 50
68078-023-022021-01-29C16284748780-1ba0f9c33-4c46-a910-e053-dadaa90a0b85All Calm™ Clinical Redness Corrector SPF 50
68078-023-242021-01-29C16284748780-1ba0f9c33-4c46-a910-e053-dadaa90a0b85All Calm™ Clinical Redness Corrector SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-023-02All Calm Clinical Redness Corrector SPF 501 mL in 1 PACKETLIQUID15
68078-023-24All Calm Clinical Redness Corrector SPF 5030 mL in 1 TUBELIQUID305
68078-023-24All Calm Clinical Redness Corrector SPF 501 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-023ALL CALM CLINICAL REDNESS CORRECTOR SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]5Current NDC, Legacy NDC, 3 package rows20241222_68b95e94-3686-4d11-9952-ec86394376ee.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-02368078-023-24, 68078-023-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIM
CYCLOMETHICONE 50THT5PCI0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
Niacinamide25X51I8RD4IACT
Disteardimonium HectoriteX687XDK09LIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
Propylene Carbonate8D08K3S51EIACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES0K5Y9U1P6MIACT
CHROMIC OXIDEX5Z09SU859IACT
ALUMINUM OXIDELMI26O6933IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
CYCLOMETHICONE 4CZ227117JEIACT
JOJOBA OIL724GKU717MIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
Glyceryl Behenate/Eicosadioate73CJJ317SRIACT
LEVOMENOL24WE03BX2TIACT
FERRIC OXIDE RED1K09F3G675IACT
PhenoxyethanolHIE492ZZ3TIACT
CRITHMUM MARITIMUM WHOLEJ7IHY79BKYIACT
TriethoxycaprylylsilaneLDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TocopherolR0ZB2556P8IACT
MAGNOLIA OFFICINALIS BARK5M609NV974IACT
Benzoic Acid8SKN0B0MIMIACT
GINGERC5529G5JPQIACT
Dehydroacetic Acid2KAG279R6RIACT
Glycolic Acid0WT12SX38SIACT
Chloroacetic Acid5GD84Y125GIACT

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
All Calm Clinical Redness Corrector SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColorescience68b95e94-3686-4d11-9952-ec86394376ee2024-12-12WarningsExact identifier
ndc (package): 68078-023-24
ndc (package): 68078-023-02
ndc (product): 68078-023
ndc11 (package): 68078002324
ndc11 (package): 68078002302
spl id: 2e084b9c-3859-4721-849f-15cdaf684a13
spl set id: 68b95e94-3686-4d11-9952-ec86394376ee

Reported adverse events (FAERS/openFDA)#

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