DAILY SPF PRIMER

Manufacturer
Lee Indie & Co Inc
Effective date
2023-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:52:59

Label at a glance#

ProductDAILY SPF PRIMER SPF 50
Active ingredientZINC 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 before sun exposure. Reapply: Use a water-resistant sunscreen if swimming or sweating 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit your time in the sun, especially from ...

Storage and handling

Protect this product from excessive heat and direct sun. Store below 90°F (32°C).

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 12%

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 CONSULT A PHYSICIAN 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 before sun exposure.
  • Reapply:
  • Use a water-resistant sunscreen if swimming or sweating
  • 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit your time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methylheptyl Isostearate, Niacinamide, Nylon-12, Methylpropanediol, Silica, Coco-Caprylate, Allantoin, Bisabolol, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Lecithin, Phenylpropanol, Tetrasodium Glutamate Diacetate, Hydrogenated Lecithin, Sodium Hydroxide, CI 77491, CI77492, CI 77499 (Iron Oxides)

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun. Store below 90°F (32°C).

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

unit_cartonunit_carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81545-102-402025-01-30C16284748780-12cef2736-5d57-d83d-e063-dadaa90ab31fINDIE LEE - DAILY SPF PRIMER SPF 50 (81545-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81545-102-40DAILY SPF PRIMERSPF 5040 mL in 1 BOTTLELOTION401
81545-102-40DAILY SPF PRIMERSPF 501 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81545-102DAILY SPF PRIMER SPF 50 (ZINC OXIDE) LOTION [LEE INDIE & CO INC]1Legacy NDC, 2 package rows20230107_eb070c0e-d7f1-f554-e053-2995a90a392b.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81545-10281545-102-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
eb070c0e-d7f0-f554-e053-2995a90a392beb070c0e-d7f1-f554-e053-2995a90a392b2023-01-06WarningsExact identifier
spl id: eb070c0e-d7f0-f554-e053-2995a90a392b
spl set id: eb070c0e-d7f1-f554-e053-2995a90a392b

Reported adverse events (FAERS/openFDA)#

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