FDA.reportPublic FDA data

Calming Perfector SPF 20 Sunscreen

Manufacturer
Colorescience
Effective date
2018-11-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:09

Label at a glance#

ProductCalming Perfector SPF 20 Sunscreen
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: After 40 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. 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 1...

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 5.4%Sunscreen
Zinc Oxide 5.4%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:
    • After 40 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours.
  • 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, Dimethicone Crosspolymer, Glycerin, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Cucumis Sativus (Cucumber) Fruit Extract, Spirulina Maxima Extract, Camellia Sinensis Leaf Extract, Opuntia Ficus-Indica Stem Extract, Palmaria Palmata Extract, Disodium Lauriminodipropionate Tocopheryl Phosphates, Citrus Paradisi (Grapefruit) Seed Extract, Ascorbic Acid, Dimethiconol, Dimethicone, Triethoxycaprylylsilane, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, 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

Distributed in USA by
Colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

colorescience®

CALMING
PERFECTOR

3-IN-1 FACE PRIMER

Neutralizes redness

Soothes & nourishes skin

Water resistant
(40 minutes)

20
Broad Spectrum
SPF 20
Sunscreen

1 fl. oz. / 30 mL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68078-017-022021-01-29C16284748780-1ba0f9c33-2d7b-a910-e053-dadaa90a0b85Calming Perfector SPF 20 Sunscreen
68078-017-182021-01-29C16284748780-1ba0f9c33-2d7b-a910-e053-dadaa90a0b85Calming Perfector SPF 20 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68078-017-02Calming Perfector SPF 20 Sunscreen1 mL in 1 PACKETLIQUID12
68078-017-18Calming Perfector SPF 20 Sunscreen30 mL in 1 TUBELIQUID302
68078-017-18Calming Perfector SPF 20 Sunscreen1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68078-017CALMING PERFECTOR SPF 20 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]2Legacy NDC, 3 package rows20181103_d735e687-e812-4fd2-9090-9cc4794ec6d6.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68078-01768078-017-18, 68078-017-02

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 OxideSOI2LOH54ZACTIB
Cyclomethicone 50THT5PCI0RIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Dimethicone Crosspolymer (450000 MPA.S at 12% in Cyclopentasiloxane)UF7620L1W6IACT
GlycerinPDC6A3C0OXIACT
Water059QF0KO0RIACT
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)9E4CO0W6C5IACT
CucumberYY7C30VXJTIACT
Arthrospira Maxima9K7IG15M0QIACT
Green Tea LeafW2ZU1RY8B0IACT
Opuntia Ficus-Indica StemMUD8892KHLIACT
Dulse7832HOY4ZQIACT
Disodium Lauriminodipropionate Tocopheryl Phosphates0K5Y9U1P6MIACT
Citrus Paradisi Seed12F08874Y7IACT
Ascorbic AcidPQ6CK8PD0RIACT
Dimethiconol (100000 CST)OSA9UP217SIACT
Dimethicone92RU3N3Y1OIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Benzoic Acid8SKN0B0MIMIACT
Dehydroacetic Acid2KAG279R6RIACT
PhenoxyethanolHIE492ZZ3TIACT
Ferric Oxide YellowEX438O2MRTIACT
Ferric Oxide Red1K09F3G675IACT
Ferrosoferric OxideXM0M87F357IACT

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
628d1905-56ab-4a83-b592-4f24b95f3289d735e687-e812-4fd2-9090-9cc4794ec6d62018-11-02WarningsExact identifier
spl id: 628d1905-56ab-4a83-b592-4f24b95f3289
spl set id: d735e687-e812-4fd2-9090-9cc4794ec6d6

Reported adverse events (FAERS/openFDA)#

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