FDA.reportPublic FDA data

Clarity Rx - Skin Defense Environmental Protection

Manufacturer
Cosmetic Solutions LLC
Effective date
2019-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:36

Label at a glance#

ProductClarity Rx - Skin Defense Environmental Protection
Active ingredientOctinoxate, Zinc Oxide
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For 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 Spectru...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxycinnamate 7.5%

Zinc Oxide 7.0%.

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.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

DOSAGE & ADMINISTRATION SECTION

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For 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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone , Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethyhexylglycerin, Polyacrylamide.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 60 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLARITYRX®

5
SKIN DEFENSE™
Environmental Protection

Naturally Moisturizing
Broad-Spectrum Sunscreen SPF 30

Net Wt 2 oz / 60g

PRINCIPAL DISPLAY PANEL - 60 g Bottle Label
PRINCIPAL DISPLAY PANEL - 60 g Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-6401-12021-01-29C16284748780-1ba0f9c33-5aa5-a910-e053-dadaa90a0b85Clarity Rx ® - Skin Defense™ Environmental Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-6401-1Clarity Rx - Skin Defense Environmental Protection60 g in 1 BOTTLE, PLASTICCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-6401CLARITY RX - SKIN DEFENSE ENVIRONMENTAL PROTECTION (OCTINOXATE AND ZINC OXIDE) CREAM [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20190927_9f52f409-ef6a-4787-b6d7-244d9047620b.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-640166163-6401-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Stearyl Alcohol2KR89I4H1YIACT
GlycerinPDC6A3C0OXIACT
Glyceryl Monostearate230OU9XXE4IACT
PEG-100 StearateYD01N1999RIACT
Glyceryl DilaurateMFL3ZIE8SKIACT
Cetostearyl Alcohol2DMT128M1SIACT
Yellow Wax2ZA36H0S2VIACT
Dimethicone92RU3N3Y1OIACT
CyclomethiconeNMQ347994ZIACT
Diisopropyl AdipateP7E6YFV72XIACT
Hexylene GlycolKEH0A3F75JIACT
PEG-40 StearateECU18C66Q7IACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Aluminum Starch OctenylsuccinateI9PJ0O6294IACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
Carnauba WaxR12CBM0EIZIACT
PEG/PPG-18/18 Dimethicone9H0AO7T794IACT
Sorbitan Tristearate6LUM696811IACT
Stearoxytrimethylsilane9862TW94B2IACT
Steareth-1004OH5W9UM87IACT
Laureth-7Z95S6G8201IACT
C13-14 IsoparaffinE4F12ROE70IACT
PhenoxyethanolHIE492ZZ3TIACT
Ethylhexylglycerin147D247K3PIACT

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
a2e9cdee-4209-45a7-a4c5-ae52d876d1f39f52f409-ef6a-4787-b6d7-244d9047620b2019-09-26WarningsExact identifier
spl id: a2e9cdee-4209-45a7-a4c5-ae52d876d1f3
spl set id: 9f52f409-ef6a-4787-b6d7-244d9047620b

Reported adverse events (FAERS/openFDA)#

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