FDA.reportPublic FDA data

78 x 36 SPF 30 Active

Manufacturer
Dermazone LLC
Effective date
2025-07-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:39

Label at a glance#

Product78 x 36 SPF 30 Active
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: * Immediately after towel drying * At least every 2 hours 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 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,...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn

lf used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early aging caused by the sun

WARNINGS

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • 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 liberally 15 minutes before sun exposure. Reapply:

  • Immediately after towel drying
  • At least every 2 hours

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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 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 6 months: Ask a Doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acetyl Ethylhexyl Polyhydroxystearate, Alcohol, Artemia Extract, C9-12 Alkane, Caprylic/Capric Triglycerides, Coco-Caprylate/Caprate, Ethylhexylglycerin,Fragrance, Glycerin, Isoamyl Laurate, Lecithin, Phenoxyethanol, Polyurethane-100, Potassium Cetyl Phosphate, Purified Water, Silica, Sodium Chloride, Sorbitan Olivate, Triheptanoin, Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BROAD SPECTRUM

78 x 36

SPF 30
ACTIVE

PROTECT YOUR SKIN
PROTECT YOUR GAME

SPORTS
SWEAT PROTECTION
80 MINUTES

3.4 OZ
96g

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58466-109-032025-07-25C16284748780-12cef2736-9a18-d83d-e063-dadaa90ab31f78 x 36 SPF 30 Active
58466-109-032025-01-30C16284748780-12cef2736-9a18-d83d-e063-dadaa90ab31f78 x 36 SPF 30 Active

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58466-109-0378 x 36 SPF 30 Active96 g in 1 TUBECREAM962
58466-109-0378 x 36 SPF 30 Active1 in 1 CARTONCREAM12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58466-10958466-109-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALCOHOL3K9958V90MIACT
C9-12 ALKANE7J5R5W72QMIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITAN OLIVATEMDL271E3GRIACT
TRIHEPTANOIN2P6O7CFW5KIACT
XANTHAN GUMTTV12P4NEEIACT

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
78 x 36 SPF 30 ActiveZINC OXIDEDermazone LLC96a8aacc-5c2f-410a-8fb4-8b3bc0f81e552025-07-25WarningsExact identifier
ndc (package): 58466-109-03
ndc (product): 58466-109
ndc11 (package): 58466010903
spl id: 1c2b73fd-1c52-4db3-982e-d937c04ceeac
spl set id: 96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55

Reported adverse events (FAERS/openFDA)#

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