FDA.reportPublic FDA data

SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30

Manufacturer
ENGLEWOOD LAB, INC.
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:09

Label at a glance#

ProductSUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 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 Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.64%

Zinc Oxide 2.98%

Purposes

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

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

OTC - STOP USE SECTION

ir rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Diemthicone, Caprylic/Capric Triglyceride, Glycerin, Aloe Barbadensis Leaf Juice, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Fragrance, Rubus Idaeus(Raspberry) Seed Extract, Chondrus Crispus Extract, Oryza Sativa (Rice) Extract, Spirulina Platensis Extract, Spirulina Maxima Extract, Panax Ginseng Root Extract, Alumina, Hyaluronic Acid, Leuconostoc/Radish Root Ferment Filtrate, Sodium Potassium Aluminum Silicate, Polyhydroxystearic Acid, Stearic Acid, Triethoxycaprylylsilane, Superoxide Dismutase, Soybean Peroxidase, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Aminomethyl Propanol, Titanium Dioxide, Xanthan Gum, Sodium Carbomer, Citric Acid

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package4Outer Package4Inner Package4Inner Package4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14268-120-30SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 3030 mL in 1 BOTTLELOTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14268-120SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENGLEWOOD LAB, INC.]4Current NDC, 1 package rows20231213_f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14268-12014268-120-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
NIACINAMIDE25X51I8RD4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
RICE GERM7N2B70SFEZIACT
ARTHROSPIRA MAXIMA9K7IG15M0QIACT
ASIAN GINSENGCUQ3A77YXIIACT
ALUMINUM OXIDELMI26O6933IACT
HYALURONIC ACIDS270N0TRQYIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
STEARIC ACID4ELV7Z65APIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE)W2T4YRA9ADIACT
BENZYL ALCOHOLLKG8494WBHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.f5c7b7ce-b3ed-3e96-e053-2995a90a8ea92023-12-12WarningsExact identifier
ndc (package): 14268-120-30
ndc (product): 14268-120
ndc11 (package): 14268012030
spl id: 0c5bef36-460c-4a81-e063-6294a90a7583
spl set id: f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9

Reported adverse events (FAERS/openFDA)#

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