Drug Facts

Manufacturer
L’Oreal USA Products Inc | L’Oreal USA, Inc.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:56

Label at a glance#

ProductMaybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 Sunscreen
Active ingredientOCTINOXATE
Label structure14 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

For sunscreen use: ● shake well ● apply liberally 15 minutes before sun exposure ● reapply at least every 2 hours ● use a water resistant sunscreen if swimming or sweating ● 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 inclu...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

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

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 if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:
● shake well

● apply liberally 15 minutes before sun exposure
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● 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 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclohexasiloxane, propylene glycol, glycerin, octyldodecanol, stearic acid, potassium cetyl phosphate, palmitic acid, PEG-100 stearate, glyceryl stearate, triethanolamine, phenoxyethanol, cetyl alcohol, talc, dimethicone, silica, methylparaben, caprylyl glycol, carbomer, fragrance, ethylparaben, capryloyl salicylic acid, xanthan gum, disodium EDTA, butylphenyl methylpropional, hexyl cinnamal, linalool, sodium palmitoyl proline, limonene, benzyl salicylate, benzyl alcohol, citronellol, hydroxycitronellal, prunus cerasus (bitter cherry) extract, rosa centifolia flower extract, nymphaea alba flower extract; may contain: mica, titanium dioxide, bismuth oxychloride, iron oxides, red 4, yellow 5

Questions or comments?

OTC - QUESTIONS SECTION

1-800-944-0730

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-196-01Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 Sunscreen30 mL in 1 TUBELOTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-196MAYBELLINE NEW YORK MASTER PRIME BY FACE STUDIO PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN (OCTINOXATE) LOTION [L’OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 1 package rows20231229_feabb713-4ef1-45b3-b34f-562e37b314d5.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-19649967-196-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 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
Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 SunscreenOCTINOXATELOreal USA Products Incfeabb713-4ef1-45b3-b34f-562e37b314d52023-12-28WarningsExact identifier
ndc (package): 49967-196-01
ndc (product): 49967-196
ndc11 (package): 49967019601
spl id: cc4d39ba-60d8-4a85-96f7-faadfc3b1ab3
spl set id: feabb713-4ef1-45b3-b34f-562e37b314d5

Reported adverse events (FAERS/openFDA)#

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