FDA.reportPublic FDA data

PHOTO FINISH FOUNDATION PRIMER SPF 20

Manufacturer
MANA PRODUCTS, INC. | MANA PRODUCTS,INC | MANA PRODUCTS,INC.
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:35

Label at a glance#

ProductPHOTO FINISH FOUNDATION PRIMER SPF 20
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE
Label structure11 sections

Indications and uses

helps prevent sunburn

Dosage and administration

For sunscreen use: apply liberally and evenly 15 minutes before sun exposure apply to all skin exposed to the sun reapply at least 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 value of 15 or higher and other sun ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.00%
Homosalate 15.00%
Octisalate 5.00%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

OTC - WHEN USING SECTION

helps prevent sunburn

WARNING

WARNINGS SECTION

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally and evenly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply at least 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 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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Polysilicone-11, Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Tocopheryl Acetate, Cola Acuminata (Kola) Seed Extract, Vitis Vinifera (Grape) Seed Extract, Carthamus Tinctorius (Safflower) Seed Oil, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Octyldodecyl Neopentanoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Acetyl Hexapeptide-8, Phenyl Trimethicone, Water\Aqua\Eau, Silica, Laureth-12, Hexyl Laurate, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Caprylyl Glycol, Hexylene Glycol, Hydrogenated Polydecene, Phenoxyethanol, Potassium Sorbate, Iron Oxides (CI 77491) <ILN39369>

OTHER INFORMATION

OTHER SAFETY INFORMATION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

RECENT MAJOR CHANGES SECTION

Dosage & Admin update

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.

PRINCIPAL DISPLAY PANAL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHOTO FINISH PRIMER SPFPHOTO FINISH PRIMER SPF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-450-01PHOTO FINISH FOUNDATION PRIMER SPF 2030 g in 1 TUBECREAM302
59735-450-01PHOTO FINISH FOUNDATION PRIMER SPF 201 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-450PHOTO FINISH FOUNDATION PRIMER SPF 20 CREAM [MANA PRODUCTS, INC.]2Legacy NDC, 2 package rows20240104_ea94d31e-8067-d884-e053-2a95a90ae579.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-45059735-450-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
SAFFLOWER OIL65UEH262ISIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CERAMIDE NGC04977SRJ5IACT
PEG-10 RAPESEED STEROL258O76T85MIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LAURETH-12OAH19558U1IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
FERRIC OXIDE RED1K09F3G675IACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
HEXYL LAURATE4CG9F9W01QIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COLA ACUMINATA SEED1F8VIW1479IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
TRIBEHENIN8OC9U7TQZ0IACT
AVOBENZONEG63QQF2NOXACTIB

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
0e127c48-e131-a961-e063-6394a90a3174ea94d31e-8067-d884-e053-2a95a90ae5792024-01-03WarningsExact identifier
spl id: 0e127c48-e131-a961-e063-6394a90a3174
spl set id: ea94d31e-8067-d884-e053-2a95a90ae579

Reported adverse events (FAERS/openFDA)#

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