1177, 1178 Sunscreen

Manufacturer
Dynarex
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:29

Label at a glance#

Product1177, 1178 Sunscreen
Active ingredientOCTINOXATE, OXYBENZONE, HOMOSALATE, OCTISALATE
Label structure9 sections

Indications and uses

. Protects from excessive heat and direct sun . Helps prevent sunburns . Higher SPF gives more sunburn protection . For skin highly sensitive to sunburn

Dosage and administration

. Apply liberally 15 minutes before sun exposure . Reapply at least every 2 hours . Children under 6 months: as a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

. Protects from excessive heat and direct sun

. Helps prevent sunburns

. Higher SPF gives more sunburn protection

. For skin highly sensitive to sunburn

Warnings

WARNINGS SECTION

For External Use Only.

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin carcer or early skin aging.

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center 800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

. Apply liberally 15 minutes before sun exposure

. Reapply at least every 2 hours

. Children under 6 months: as a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Antaron V-220, Butylated Hydroxyanisole, Butylated Hydroxytoluene, Carbopol Ultrez 10, Ceteareth 20, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glyceryl Stearate SE, Methylparaben, Propylparaben, Purified Water, Sorbitan Monostearate, Sorbitol Solution, Stearic Acid, Trolamine

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1177 BX MASTER1177 BX MASTER1177 Sunscreen

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1177-1178 DM MASTER1177-1178 DM MASTER1177, 1178 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-177-011177, 1178 Sunscreen24 in 1 CASECREAM244
67777-177-021177, 1178 Sunscreen1000 in 1 CASECREAM10004
67777-177-021177, 1178 Sunscreen3.5 g in 1 PACKETCREAM3.54
67777-177-111177, 1178 Sunscreen25 in 1 BOXCREAM254
67777-177-111177, 1178 Sunscreen3.5 g in 1 PACKETCREAM3.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-1771177, 1178 SUNSCREEN CREAM [DYNAREX]4Current NDC, Legacy NDC, 5 package rows20241122_c3142ddb-74ea-a7d1-e053-2a95a90a26f3.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-17767777-177-11, 67777-177-01, 67777-177-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
1177, 1178 Sunscreen1177, 1178 SUNSCREENDynarexc3142ddb-74ea-a7d1-e053-2a95a90a26f32024-11-20WarningsExact identifier
ndc (package): 67777-177-11
ndc (package): 67777-177-02
ndc (package): 67777-177-01
ndc (product): 67777-177
ndc11 (package): 67777017702
ndc11 (package): 67777017711
ndc11 (package): 67777017701
spl id: 2758c466-8d6c-3227-e063-6394a90ad9d1
spl set id: c3142ddb-74ea-a7d1-e053-2a95a90a26f3

Reported adverse events (FAERS/openFDA)#

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