Label at a glance#

ProductMILANI MAKE IT LAST SUNSCREEN SETTING SPF 30

Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

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 sun Directions

Dosage and administration

• spray liberally and spread evenly by hand 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 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 m...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Homosalate 9%

Octisalate 4.5%

Octocrylene 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 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

• spray liberally and spread evenly by hand 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 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

Sun Protection Measures.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Alcohol Denat., Isododecane, Butyloctyl Salicylate, PVP, Water, C24-28 Alkyldimethylsiloxy Trimethylsiloxysilicate, Tropaeolum Majus Flower/Leaf/Stem Extract, Ethylhexylglycerin, Phenoxyethanol, Fragrance

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageInner Package

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71435-0004-0	2023-12-18	C162847	48780-1	0191ceaa-6d2c-198a-e063-dbdaa90aec3e	MILANI MAKE IT LAST SUNSCREEN SETTING SPRAY SPF 30
71435-0004-0	2023-07-28	C162847	48780-1	0191ceaa-6d2c-198a-e063-dbdaa90aec3e	MILANI MAKE IT LAST SUNSCREEN SETTING SPRAY SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71435-0004-0	MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	60 mL in 1 BOTTLE	LIQUID	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71435-0004	MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LIQUID [NEW MILANI GROUP, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20231219_8f52f614-1cfe-4ef0-8cb6-37afbfddf44c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
ALCOHOL
ISODODECANE
BUTYLOCTYL SALICYLATE
POVIDONE, UNSPECIFIED
WATER
TROPAEOLUM MAJUS FLOWERING TOP
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
AVOBENZONE
HOMOSALATE
OCTISALATE
OCTOCRYLENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71435-0004	71435-0004-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
ISODODECANE	A8289P68Y2	IACT
BUTYLOCTYL SALICYLATE	2EH13UN8D3	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
WATER	059QF0KO0R	IACT
TROPAEOLUM MAJUS FLOWERING TOP	RGT30824HY	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	New Milani Group, LLC	8f52f614-1cfe-4ef0-8cb6-37afbfddf44c	2023-12-12	Warnings	Exact identifier ndc (package): 71435-0004-0 ndc (product): 71435-0004 ndc11 (package): 71435000400 spl id: 0c5d0e48-2faf-0d70-e063-6394a90a97f8 spl set id: 8f52f614-1cfe-4ef0-8cb6-37afbfddf44c

Reported adverse events (FAERS/openFDA)#

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

MILANI MAKE IT LAST SUNSCREEN SETTING SPRAY SPF 30