FDA.reportPublic FDA data

4oz SPF 30 Sunscreen Lotion

Manufacturer
Webb Business Promotions
Effective date
2022-01-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:46:18

Label at a glance#

ProductSun Screen
Active ingredientTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure6 sections

Dosage and administration

Apply to all exposed skin prior to sun exposure. Reapply as needed especially after swimming or perspiring. Consult a physician before using on children under the age of 6 months.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Purpose

Sun Screen

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.0%

Octisalate 4.0%

Titanium Dioxide 4.0%

Benzophenone 3.0%

Directions

INTENDED USE OF THE DEVICE

Apply to all exposed skin prior to sun exposure. Reapply as needed especially after swimming or perspiring. Consult a physician before using on children under the age of 6 months.

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Avoid contact with eyes

Keep out of reach of children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Myristate, Caprylic/Capric Triglyceride, Cetostearyl Alcohol, Glycerin, Alkyl (C12-15) Benzoate, Ceteth-25, Glyceryl Stearate, Fragrance, DMDM Hydantoin, Methylparaben, Proplyparaben

SPF 30 Sunscreen Lotion (4oz) ASI #95838 Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SSL4SSL4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70445-157-012023-07-28C16284748780-19d75b9d0-8e54-f424-e053-dadaa90a57ce4oz SPF 30 Sunscreen Lotion
70445-157-012020-04-17C16284748780-19d75b9d0-8e54-f424-e053-dadaa90a57ce4oz SPF 30 Sunscreen Lotion
70445-157-012020-01-31C16284748780-19d75b9d0-8e54-f424-e053-dadaa90a57ce4oz SPF 30 Sunscreen Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70445-157-01Sun Screen114 g in 1 BOTTLE, PLASTICLOTION1145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70445-157SUN SCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LOTION [WEBB BUSINESS PROMOTIONS]5Legacy NDC, 1 package rows20220105_3f25a51b-a2a2-1301-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70445-15770445-157-01

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
DMDM HYDANTOINBYR0546TOWIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETETH-255KLY4IOG20IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB

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
d4c7238b-27c2-5b53-e053-2a95a90a58da3f25a51b-a2a2-1301-e054-00144ff8d46c2022-01-04WarningsExact identifier
spl id: d4c7238b-27c2-5b53-e053-2a95a90a58da
spl set id: 3f25a51b-a2a2-1301-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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