FDA.reportPublic FDA data

Milani Prime Protect SPF 30 Face Primer

Manufacturer
The Milani Group, Inc.
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:40:41

Label at a glance#

ProductMilani Prime Protect SPF 30 Face Primer
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and uses

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

Dosage and administration

For Sunscreen use: Apply generously and evenly 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 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 t...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone 3.0%Sunscreen
Octinoxate 7.3%Sunscreen
Octocrylene 3.0%Sunscreen
Oxybenzone 2.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection (see Directions), decreases the risk of skin cancer and early skin aging caused by 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For Sunscreen use:

  • Apply generously and evenly 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 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, and sun glasses
    • 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, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, PEG-8, phenoxyethanol, polysorbate 80, xanthan gum, tocopherol, ethylhexylglycerin, citric acid, retinyl palmitate, disodium EDTA, glycine soja (soybean) oil, yellow 5 (CI 19140), red 40 (CI 16035).

Questions or comments?

OTC - QUESTIONS SECTION

Call 866–789–8002 Monday – Friday (8 a.m. to 5 p.m. PST)

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MILANI

PRIME
PROTECT

SPF 30 FACE PRIMER

BROAD SPECTRUM SUNSCREEN
+ UVA/UVB PROTECTION

1 FL OZ / 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71435-8202-62021-12-02C16284748780-19d75b9d0-8b90-f424-e053-dadaa90a57ceMilani Prime Protect SPF 30 Face Primer
71435-8202-62020-01-31C16284748780-19d75b9d0-8b90-f424-e053-dadaa90a57ceMilani Prime Protect SPF 30 Face Primer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71435-8202-6Milani Prime Protect SPF 30 Face Primer30 mL in 1 TUBECREAM3011
71435-8202-6Milani Prime Protect SPF 30 Face Primer1 in 1 CARTONCREAM111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71435-8202MILANI PRIME PROTECT SPF 30 FACE PRIMER (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [THE MILANI GROUP, INC.]11Current NDC, Legacy NDC, 2 package rows20241207_d557d554-5161-482c-bd78-7721c7dc9a6e.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71435-820271435-8202-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
PEG-8 STEARATE2P9L47VI5EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SOYBEAN OIL241ATL177AIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
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
Milani Prime Protect SPF 30 Face PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONEThe Milani Group, Inc.d557d554-5161-482c-bd78-7721c7dc9a6e2024-12-04WarningsExact identifier
ndc (package): 71435-8202-6
ndc (product): 71435-8202
ndc11 (package): 71435820206
spl id: 2874ab15-80ca-c108-e063-6294a90a43a0
spl set id: d557d554-5161-482c-bd78-7721c7dc9a6e

Reported adverse events (FAERS/openFDA)#

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