ZRII NEW DAY

Manufacturer
ZRII, LLC | Westwood Laboratories Inc.
Effective date
2016-07-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:46:29

Label at a glance#

ProductZRII NEW DAY BROAD SPECTRUM SPF-30
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
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 generously 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 measu...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone  3.0%
Homosalate  5.0%
Octinoxate  5.0%
Octocrylene  2.7%
Oxybenzone  5.0%

PURPOSE

OTC - PURPOSE SECTION

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
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 the reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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

OTHER INFORMATION

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua, Carthamus Tinctorius (Safflower) Oleosomes, Glyceryl Stearate, Cetearyl Alcohol, Isodecyl Neopentanoate, Ceteareth-20, Cetyl Alcohol, Niacinamide, Caprylic/Capric Triglycerides (and) Sea Whip Extract, Diisopropyl Sebacate, Lauryl Lactate, Ascorbyl Glucoside, Tocopheryl Acetate, 7-Dehydrocholesterol, Sodium Polyacrylate, Sodium Citrate, Carbomer, Hexylene Glycol, Disodium Edta, Sodium Hydroxide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Citric Acid

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll free 1-866-349-9911

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

a1801V1_ZriiNew_SPF_CartonBoxa1801V1_ZriiNew_SPF_CartonBox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70528-018-512020-01-31C16284748780-19d75b9d0-c478-f424-e053-dadaa90a57ce2ab19062-25ab-46a1-9f36-d02dd1c66f38

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70528-018-11ZRII NEW DAYBROAD SPECTRUM SPF-3050 mL in 1 TUBECREAM502
70528-018-51ZRII NEW DAYBROAD SPECTRUM SPF-301 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70528-018ZRII NEW DAY BROAD SPECTRUM SPF-30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [ZRII, LLC]2Legacy NDC, 2 package rows20160706_2ab19062-25ab-46a1-9f36-d02dd1c66f38.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70528-01870528-018-11, 70528-018-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
971e664f-278b-42de-b15c-a86cee7c44a32ab19062-25ab-46a1-9f36-d02dd1c66f382016-07-05WarningsExact identifier
spl id: 971e664f-278b-42de-b15c-a86cee7c44a3
spl set id: 2ab19062-25ab-46a1-9f36-d02dd1c66f38

Reported adverse events (FAERS/openFDA)#

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