FDA.reportPublic FDA data

DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen

Manufacturer
PureTek Corporation
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:22:30

Label at a glance#

ProductDermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

■ Helps prevent sunburn. ■ If used as a directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.   

Dosage and administration

■ Apply liberally 15 minutes before sun exposure ■ Use a water-resistant sunscreen if swimming or sweating or immediately after towel drying    ■ Reaply: ■ at least every 2 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 incl...

Storage and handling

■ Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients (% w/w)

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%

Octinoxate 3%

Octisalate 3%

Titanium Dioxide 1.25%

Purposes

OTC - PURPOSE SECTION

Sunscreen (Avobenzone 2.5%)
Sunscreen (Octinoxate 3%)
Sunscreen (Octisalate 3%)
Sunscreen (Titanium Dioxide 1.25%) 

Uses

INDICATIONS & USAGE SECTION

■ Helps prevent sunburn.

■ If used as a directed with other sun protection measures (see Directions), decreases the risk of 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 eyes

■ Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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 ■ Use a water-resistant sunscreen if swimming or sweating or immediately after towel drying   
■ Reaply: ■ at least every 2 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 six months of age: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Emulsifying Wax, Shea butter, Stearic Acid, Ethylhexyl Palmitate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Sunflower Seed Oil, Isopropyl Isostearate, Vitamin E, Potassium Sorbate, Xanthan Gum, Sodium Benzoate.

Other information

STORAGE AND HANDLING SECTION

■ Protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

1.800.611.4270 

Dermacin ®Rx Skin Moisturizing Ultra SPF 50 Sunscreen Lotion (Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISTRIBUTED BY:

PureTek Corporation
San Fernando, CA 91340

image descriptionimage description

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-568-05DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen56 mL in 1 BOTTLELOTION565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-568DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LOTION [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241004_86eb06cc-d63f-4500-a52e-14ef99a56532.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-56859088-568-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLAWAX POLYSORBATEQ504PL8E0VIACT
SHEA BUTTERK49155WL9YIACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYL PALMITATE2865993309IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT
SUNFLOWER OIL3W1JG795YIIACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
ndc (package): 59088-568-05
ndc (product): 59088-568
ndc11 (package): 59088056805
spl id: 23848119-f005-7528-e063-6394a90a9a0e
spl set id: 86eb06cc-d63f-4500-a52e-14ef99a56532

Reported adverse events (FAERS/openFDA)#

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