AVOBENZONE, OCTINOXATE, OCTOCRYLENE

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 23:00:58

Label at a glance#

Productflormar ADVICE Skin Geometry Purely Moisturizing Day Sunscreen Broad Spectrum SPF 15 Dry and Sensitive Skin
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
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

Apply on cleansed face, neck and neckline by gently massaging every morning. 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 an...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.5%
Octinoxate 4%
Octocrylene 2%

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 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 on cleansed face, neck and neckline by gently massaging every morning.
  • 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, cyclopenatsiloxane, hydrogenated polydecene, isononyl isononanoate, cetearyl olivate, butylene glycol, aluminum starch octenylsuccinate, cetearyl alcohol, sorbitan olivate, glycerin, soybean (Glycine soja) oil, phenoxyethanol, shea (Butyrospermum parkii) butter, dimethicone, apricot (Prunus armeniaca) kernel oil, cetyl palmitate, sorbitan palmitate, saccharide isomerate, fragrance, polyacrylamide, ethylhexylglycerin, C13-14 isoparaffin, arnica (Arnica montana) flower extract, disodium EDTA, xanthan gum, caprylyl glycol, hydrolyzed vegetable protein, laureth-7, citric acid, pomegranate (Punica granatum) fruit extract, sodium citrate, pectin, arginine, proline, serine, glucose, fig (Ficus carica) fruit extract, cotton (Gossypium hirsutum) seed extract, linseed (Linum usitatissimum) seed extract, tocopherol, carrageenan (Chondrus cripus).

flormar ADVICE Skin Geometry Purely Moisturizing Day Cream Sunscreen Broad Spectrum SPF 15 Dry and Sensitive Skin 50ml (61722-021-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Day Cream Dry Sensitive Inner LabelDay Cream Dry Sensitive Inner Label

Day Cream Dry Sensitive Outer LabelDay Cream Dry Sensitive Outer Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61722-021-00flormar ADVICE Skin Geometry Purely Moisturizing Day Sunscreen Broad Spectrum SPF 15 Dry and Sensitive Skin50 mL in 1 JARCREAM504
61722-021-00flormar ADVICE Skin Geometry Purely Moisturizing Day Sunscreen Broad Spectrum SPF 15 Dry and Sensitive Skin1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61722-021FLORMAR ADVICE SKIN GEOMETRY PURELY MOISTURIZING DAY SUNSCREEN BROAD SPECTRUM SPF 15 DRY AND SENSITIVE SKIN (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) CREAM [KOSAN KOZMETIK SANAYI VE TICARET A.S.]4Legacy NDC, 2 package rows20191019_57d05ca0-a032-4f5b-8d90-2063fa2ec083.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O62942
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06A2
ARGININEINACTIVE INGREDIENT94ZLA3W45F2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE702
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ2
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JO2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X2
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1X2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
COTTON SEEDINACTIVE INGREDIENTDI0ZRJ0MXN2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W22
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FIGINACTIVE INGREDIENTTGD87RII2U2
FLAX SEEDINACTIVE INGREDIENT4110YT348C2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX2
LAURETH-7INACTIVE INGREDIENTZ95S6G82012
PECTININACTIVE INGREDIENT89NA02M4RX2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POMEGRANATEINACTIVE INGREDIENT56687D1Z4D2
PROLINEINACTIVE INGREDIENT9DLQ4CIU6V2
SACCHARIDE ISOMERATEINACTIVE INGREDIENTW8K377W98I2
SERINEINACTIVE INGREDIENT452VLY94022
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SORBITAN MONOPALMITATEINACTIVE INGREDIENT77K6Z421KU2
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GR2
SOYBEAN OILINACTIVE INGREDIENT241ATL177A2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61722-02161722-021-00

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

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 7 · 363 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROLINEPROLINE9DLQ4CIU6VINJECTION / INTRAVENOUS0.8 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJLOTION / TOPICAL0.5 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, SOLUTION / INTRAVENOUS0.29 %w/vExact identifier — unii candidate
11 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3600 mgExact identifier — unii candidate
11 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XOINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii candidate
21 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJGRANULE, FOR SUSPENSION / ORAL161 mgExact identifier — unii candidate
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR6240 mgExact identifier — unii candidate
11 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRASPINAL75 mgExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TROCHE / ORAL903.5 mgExact identifier — unii candidate
21 equally ranked IID candidates
ARGININEARGININE94ZLA3W45FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
11 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJPOWDER, FOR SUSPENSION / ORAL15 mgExact identifier — unii candidate
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
PECTINPECTIN89NA02M4RXTABLET / ORAL1 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / BUCCALNAExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 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
952e8cdb-6718-4533-e053-2a95a90a61d757d05ca0-a032-4f5b-8d90-2063fa2ec0832019-10-18WarningsExact identifier
spl id: 952e8cdb-6718-4533-e053-2a95a90a61d7
spl set id: 57d05ca0-a032-4f5b-8d90-2063fa2ec083

Reported adverse events (FAERS/openFDA)#

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