FDA.reportPublic FDA data

MAKEUP SUN PRIMER

Manufacturer
STW ENTERPRISE INC. | Nowcos Co., Ltd.
Effective date
2015-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:18

Label at a glance#

ProductMAKEUP SUN PRIMER
Active ingredientOCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate 7.00%
Titanium Dioxide 4.11%
Zinc Oxide 4.93%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Silica, Triethylhexanoin, Phenethyl Benzoate, Butyrospermum Parkii (Shea) Butter, Bis-Ethylhexyloxyphenol MethoxyphenylTriazine, Dimethicone/Vinyl Dimethicone Crosspolymer, Ceresin, Cholesteryl Isostearate, Trimethylsiloxysilicate, PEG-10 Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Citrus Grandis (Grapefruit) Peel Oil, Ocimum Basilicum (Basil) Oil, Geranium Maculatum Oil, Propylene Glycol, Hydroxypropyl Bisstearamide MEA, Macadamia Integrifolia Seed Oil, Butylene Glycol, Argania Spinosa Kernel Oil, Dipropylene Glycol, Behenyl Alcohol, Ceteareth-20, Cholesterol, Cetearyl Alcohol, Squalane, Tricaprin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70117-001-022020-01-31C16284748780-19d75b9d0-52c0-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70117-001-01MAKEUP SUN PRIMER50 mL in 1 CONTAINERCREAM502
70117-001-02MAKEUP SUN PRIMER1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70117-001MAKEUP SUN PRIMER (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [STW ENTERPRISE INC.]2Legacy NDC, 2 package rows20151209_1be9d02e-64c1-4a62-9549-e0819c9d811f.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70117-00170117-001-01, 70117-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
CYCLOMETHICONE 6XHK3U310BAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
PHENETHYL BENZOATE0C143929GKIACT
SHEA BUTTERK49155WL9YIACT
BEMOTRIZINOLPWZ1720CBHIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
CERESINQ1LS2UJO3AIACT
CHOLESTERYL ISOSTEARATEJD5KDN9464IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CITRUS MAXIMA FRUIT RIND OIL8U3877WD44IACT
BASIL OILZ129UMU8LEIACT
GERANIUM MACULATUM ROOT OILH2E371EDYXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROXYPROPYL BISSTEARAMIDE MONOETHANOLAMIDEEQ4H84545FIACT
MACADAMIA OIL515610SU8CIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ARGAN OIL4V59G5UW9XIACT
DIPROPYLENE GLYCOLE107L85C40IACT
DOCOSANOL9G1OE216XYIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CHOLESTEROL97C5T2UQ7JIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
TRICAPRINO1PB8EU98MIACT

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
a9df4a5e-3c87-4a4d-9af7-2561324bd4ff1be9d02e-64c1-4a62-9549-e0819c9d811f2015-12-08WarningsExact identifier
spl id: a9df4a5e-3c87-4a4d-9af7-2561324bd4ff
spl set id: 1be9d02e-64c1-4a62-9549-e0819c9d811f

Reported adverse events (FAERS/openFDA)#

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