flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige

Manufacturer: Kosan Kozmetik Sanayi ve Ticaret A.S.
Effective date: 2019-10-18
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:01:10

Label at a glance#

Productflormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige

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 5%

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, dimethicone, cyclopentasiloxane, butylene glycol, PEG-10 dimethicone, polymethylsilsesquioxane, trimethylsiloxysilicate, disteardimonium hectorite, glycerine, SD alcohol 40-B, phenoxyethanol, sodium chloride, polysilicone-11, triethoxycaprylylsilane, aluminum hydroxide, sodium PCA, Urea, fragrance, ethylhexylglycerin, algae extract, soluble collagen, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, sodium hyaluronate, chlorphenesin, propylene glycol, fig (Ficus carica) fruit extract, cotton (Gossypium hirsutum) seed extract, linseed (Linum usitatissiumum) seed extract, sodium dehydroacetate, titanium dioxide, iron oxides.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soft Touch 1Soft Touch 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61722-186-00	2021-01-29	C162847	48780-1	ba0f9c33-1575-a910-e053-dadaa90a0b85	flormar Soft Touch Foundation Cream Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61722-186-00	flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige	1 in 1 BOX	CREAM	1		3
61722-186-00	flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige	30 mL in 1 TUBE	CREAM	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61722-186	FLORMAR SOFT TOUCH FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 ST08 BRONZE BEIGE (OCTINOXATE) CREAM [KOSAN KOZMETIK SANAYI VE TICARET A.S.]	3	Legacy NDC, 2 package rows	20191019_b377195f-3eee-4357-af3e-eda158ba2748.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FLAX SEED	INACTIVE INGREDIENT	4110YT348C	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE	INACTIVE INGREDIENT	D2QHA03458	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TREHALOSE	INACTIVE INGREDIENT	B8WCK70T7I	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	1
UREA	INACTIVE INGREDIENT	8W8T17847W	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige
OCTINOXATE
WATER
DIMETHICONE
CYCLOMETHICONE 5
BUTYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
GLYCERIN
PHENOXYETHANOL
SODIUM CHLORIDE
TRIETHOXYCAPRYLYLSILANE
ALUMINUM HYDROXIDE
SODIUM PYRROLIDONE CARBOXYLATE
UREA
ETHYLHEXYLGLYCERIN
TREHALOSE
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
HYALURONATE SODIUM
CHLORPHENESIN
PROPYLENE GLYCOL
FLAX SEED
SODIUM DEHYDROACETATE
TITANIUM DIOXIDE
FERRIC OXIDE RED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61722-186	61722-186-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
DIMETHICONE	92RU3N3Y1O	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
DISTEARDIMONIUM HECTORITE	X687XDK09L	IACT
GLYCERIN	PDC6A3C0OX	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
SODIUM PYRROLIDONE CARBOXYLATE	469OTG57A2	IACT
UREA	8W8T17847W	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
TREHALOSE	B8WCK70T7I	IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE	D2QHA03458	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FLAX SEED	4110YT348C	IACT
SODIUM DEHYDROACETATE	8W46YN971G	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB

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 · 379 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
UREA	UREA	8W8T17847W	INSERT / VAGINAL		50 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
UREA	UREA	8W8T17847W	TABLET, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
953068b8-c5cd-51db-e053-2995a90abfbf			b377195f-3eee-4357-af3e-eda158ba2748	2019-10-18	Warnings	Exact identifier spl id: 953068b8-c5cd-51db-e053-2995a90abfbf spl set id: b377195f-3eee-4357-af3e-eda158ba2748

Reported adverse events (FAERS/openFDA)#

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