Milani Prime Protect Spf 30 Face Primer Cream
FDA Label NDC 71435-8202

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Milani Group, Inc. for the product Milani Prime Protect Spf 30 Face Primer (NDC 71435-8202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

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

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

Warnings

  • For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

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

Inactive Ingredients

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?

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

Principal Display Panel - 30 Ml Tube Carton

MILANI

PRIME
PROTECT

SPF 30 FACE PRIMER

BROAD SPECTRUM SUNSCREEN
+ UVA/UVB PROTECTION

1 FL OZ / 30 mL

* Please review the disclaimer below.