FDA.reportPublic FDA data

PREP AND PRIME FIX PLUS SPF 30 BROAD SPECTRUM SUN SPRAY

Manufacturer
MAKEUP ART COSMETICS | Estee Lauder Companies Inc. | Whitman Laboratories Ltd. | ESTEE LAUDER COMPANY, THE | Estee Lauder Cosmetics Ltd. | Estee Lauder N.V. | NORTHTEC INC | NORTHTEC PALC | Len-Ron Manufacturing Division of Aramis Inc. | PADC 1
Effective date
2021-07-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:39:57

Label at a glance#

ProductPREP AND PRIME FIX PLUS SPF 30 BROAD SPECTRUM SUN
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply every two 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,...

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
Homosalate 4.0%Sunscreen
Octinoxate 6.0%Sunscreen
Octisalate 3.0%Sunscreen
Octocrylene 2.0%Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply every two 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

Shake very well before use – allowing for SPF and Powder ingredients to be evenly emulsified and distributed.

With eyes and mouth completely closed, mist face evenly while holding bottle 10-12 inches away from face.

Can be used before makeup and after makeup application.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat., caprylic/capric triglyceride, methyl methacrylate crosspolymer, polypropylene, butyloctyl salicylate, pvp/hexadecene copolymer, dicaprylyl carbonate, isododecane, fragrance (parfum), citral, geraniol, limonene, linalool <iln45848>

Other Information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 100 ML Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

M•A•C
PREP+PRIME

fix+
spf30

FIX+
SPF 30 SUN SPRAY
BROAD SPECTRUM SPF 30

3.4 FL. OZ. LIQ./100 ML e

PRINCIPAL DISPLAY PANEL - 100 ML Bottle Carton
PRINCIPAL DISPLAY PANEL - 100 ML Bottle Carton

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40046-008040046-0080-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALCOHOL3K9958V90MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER657L0NC5MTIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ISODODECANEA8289P68Y2IACT
CITRALT7EU0O9VPPIACT
GERANIOLL837108USYIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT

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
0fbdb825-24eb-4389-b647-2bc34186ab46874af9c2-8296-441a-832a-a0b24bf353082021-07-21WarningsExact identifier
spl set id: 874af9c2-8296-441a-832a-a0b24bf35308

Reported adverse events (FAERS/openFDA)#

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