FDA.reportPublic FDA data

Milani SPF BFF 30 Primer

Manufacturer
New Milani Group, LLC
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:08

Label at a glance#

ProductMilani SPF BFF 30 Primer
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure8 sections

Indications and uses

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

Dosage and administration

apply generously and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor.  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: ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Octinoxate 7.3% Octocrylene 3% Oxybenzone 2%


Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

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

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor.
  •  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: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, and sunglasses

Other information

SPL UNCLASSIFIED 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, Polysorbate 80, Xanthan Gum, Tocopherol, Glycine Soja (Soybean) Oil, Retinyl Palmitate, Ethylhexylglycerin, Citric Acid, Disodium EDTA, Phenoxyethanol, Yellow 5, Red 40.

Questions or comments?

OTC - QUESTIONS SECTION

Call 866-789-8002 Monday - Friday (7 a.m. to 3:30 p.m. PST)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelFront LabelFront Label

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71435-0001-0Milani SPF BFF 30 Primer30 mL in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71435-0001MILANI SPF BFF 30 PRIMER (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NEW MILANI GROUP, LLC]3Current NDC, Legacy NDC, 1 package rows20231213_c7a1f2a7-d299-2116-e053-2995a90ad8c5.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71435-000171435-0001-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM ACRYLATE7C98FKB43HIACT
SODIUM ACRYLOYLDIMETHYLTAURATE2T9Q6EKI0GIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 806OZP39ZG8HIACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 40WZB9127XOAIACT
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 SPF BFF 30 PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONENew Milani Group, LLCc7a1f2a7-d299-2116-e053-2995a90ad8c52023-12-12WarningsExact identifier
ndc (package): 71435-0001-0
ndc (product): 71435-0001
ndc11 (package): 71435000100
spl id: 0c5cfa6d-c875-7bad-e063-6294a90a1f87
spl set id: c7a1f2a7-d299-2116-e053-2995a90ad8c5

Reported adverse events (FAERS/openFDA)#

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