FDA.reportPublic FDA data

flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle

Manufacturer
Kosan Kozmetik Sanayi ve Ticaret A.S.
Effective date
2019-10-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:01:13

Label at a glance#

Productflormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle
Active ingredientOCTINOXATE
Label structure7 sections

Indications and uses

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

Dosage and administration

Shake well before use. Apply liberally 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 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 ti...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or brokenskin

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

  • Shake well before use.
  • Apply liberally 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 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.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, isonnonyl isononanoate, diethylhexyl malate, butylene glycol, sorbitan olivate, HDI/trimethylol hexyllactone crosspolymer, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, magnesium aluminum silicate, glycerin, sweet almond (Prunus amygdalus dulcis) oil, polyglyceryl-4 isostearate, hydrogenated olive (Olea europaea) oil, phenoxyethanol, aluminum hydroxide, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, triethoxycaprylylsilane, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, olive (Olea europaea) fruit oil, stearic acid, bisabolol, fragrance, methylparaben, propylene glycol, olive (Olea europaea) oil unsaponifiables, PEG-8, silica, tocopherol, glyceryl acrylate/acrylic acid copolymer, ascorbyl palmitate, PVM/MA copolymer, ascorbic acid, citric acid, propylparaben, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides.

flormar PERFECT COVERAGE FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle 30ml (61722-080-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Perfect Coverage 1
Perfect Coverage 1

Perfect Coverage 2
Perfect Coverage 2

Perfect Coverage 3
Perfect Coverage 3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61722-080-002021-01-29C16284748780-1ba0f9c33-33db-a910-e053-dadaa90a0b85flormar PERFECT COVERAGE FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61722-080-00flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle30 mL in 1 BOTTLECREAM304
61722-080-00flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61722-080FLORMAR PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 101 PASTELLE (OCTINOXATE) CREAM [KOSAN KOZMETIK SANAYI VE TICARET A.S.]4Legacy NDC, 2 package rows20191019_d472744e-b798-475e-8236-508e555ba2a3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964K2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R2
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N2
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV692
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
COUMARININACTIVE INGREDIENTA4VZ22K1WT2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DIETHYLHEXYL MALEATEINACTIVE INGREDIENTC2F7JHI12L2
GERANIOLINACTIVE INGREDIENTL837108USY2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01Q2
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555B2
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T2
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S72
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GR2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61722-08061722-080-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DIETHYLHEXYL MALEATEC2F7JHI12LIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SORBITAN OLIVATEMDL271E3GRIACT
HEXYL LAURATE4CG9F9W01QIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
GLYCERINPDC6A3C0OXIACT
ALMOND OIL66YXD4DKO9IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
XANTHAN GUMTTV12P4NEEIACT
STEARIC ACID4ELV7Z65APIACT
LEVOMENOL24WE03BX2TIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PROPYLPARABENZ8IX2SC1OHIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
GERANIOLL837108USYIACT
COUMARINA4VZ22K1WTIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 645 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NTABLET / ORAL7.14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / OPHTHALMIC46 mgExact identifier — unii candidate
36 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLIQUID / ORAL82 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
36 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAMUSCULAR20.3 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCGRANULE, FOR SUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCAPSULE / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
25 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates

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
952ead8b-42cf-2ddd-e053-2a95a90a73afd472744e-b798-475e-8236-508e555ba2a32019-10-18WarningsExact identifier
spl id: 952ead8b-42cf-2ddd-e053-2a95a90a73af
spl set id: d472744e-b798-475e-8236-508e555ba2a3

Reported adverse events (FAERS/openFDA)#

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