SPA SKILHA

Manufacturer: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Effective date: 2012-06-07
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:28

Label at a glance#

ProductSPA SKILHA HELIOPROT AB SPF 40

Active ingredientBEMOTRIZINOL, OCTINOXATE, AVOBENZONE, TITANIUM DIOXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, titanium dioxide and bis-ethylhexyl oxyphenol methoxyphenyl triazine offers total protection and wide spectrum against the UVA and UVB.

OTC - PURPOSE SECTION

As dermoprotective solar screen, moisturizes and nourishes. Delays photo-aging and prevents skin cancer.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Use this product when you exposed to the sun. SPF 40 UVA / UVB

WARNINGS SECTION

Avoid contact with eyes, do not use in the children under (6) six months of age.

DOSAGE & ADMINISTRATION SECTION

- Apply generously before sun exposure.
- Reapply after (6) six hours.

INACTIVE INGREDIENT SECTION

Its composition is photo stable, perfectly adjusted to any state and any contidtion of the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL IMAGE OF THE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66854-025-01	2019-11-13	C162847	48780-1	97449f38-d178-f6ea-e053-dbdaa90aa703	SPA SKILHA HELIOPROT AB SPF 40
66854-025-02	2019-11-13	C162847	48780-1	97449f38-d178-f6ea-e053-dbdaa90aa703	SPA SKILHA HELIOPROT AB SPF 40
66854-025-03	2019-11-13	C162847	48780-1	97449f38-d178-f6ea-e053-dbdaa90aa703	SPA SKILHA HELIOPROT AB SPF 40
66854-025-05	2019-11-13	C162847	48780-1	97449f38-d178-f6ea-e053-dbdaa90aa703	SPA SKILHA HELIOPROT AB SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-025-01	SPA SKILHA HELIOPROT AB SPF 40	9 g in 1 JAR	CREAM	9	1
66854-025-02	SPA SKILHA HELIOPROT AB SPF 40	33 g in 1 JAR	CREAM	33	1
66854-025-03	SPA SKILHA HELIOPROT AB SPF 40	60 g in 1 TUBE	CREAM	60	1
66854-025-04	SPA SKILHA HELIOPROT AB SPF 40	15 g in 1 TUBE	CREAM	15	1
66854-025-05	SPA SKILHA HELIOPROT AB SPF 40	20 in 1 BOX	CREAM	20	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-025	SPA SKILHA HELIOPROT AB SPF 40 (BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE) CREAM [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 5 package rows	20120630_ff3ef5f7-4846-48c6-aebc-26723f7f2320.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
BEMOTRIZINOL	ACTIVE INGREDIENT	PWZ1720CBH	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
BEMOTRIZINOL	ACTIVE MOIETY	PWZ1720CBH	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
CETEARETH-12	INACTIVE INGREDIENT	7V4MR24V5P	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DIMETHICONOL (41 MPA.S)	INACTIVE INGREDIENT	343C7U75XW	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)	INACTIVE INGREDIENT	5WE8P977RQ	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
WHEAT GERM OIL	INACTIVE INGREDIENT	14C97E680P	1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

SPA SKILHA HELIOPROT AB SPF 40
BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE
BEMOTRIZINOL
OCTINOXATE
AVOBENZONE
TITANIUM DIOXIDE
ALUMINUM OXIDE
DIMETHICONE
SILICON DIOXIDE
WATER
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
GLYCERIN
CYCLOMETHICONE
CETOSTEARYL ALCOHOL
SODIUM CETOSTEARYL SULFATE
CETEARETH-12
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)
WHEAT GERM OIL
.ALPHA.-TOCOPHEROL ACETATE, D-
CYCLOMETHICONE 5
DIMETHICONOL (41 MPA.S)
DIAZOLIDINYL UREA
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66854-025	66854-025-01, 66854-025-02, 66854-025-03, 66854-025-04, 66854-025-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BEMOTRIZINOL	PWZ1720CBH	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ALUMINUM OXIDE	LMI26O6933	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
GLYCERIN	PDC6A3C0OX	IACT
CYCLOMETHICONE	NMQ347994Z	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	IACT
CETEARETH-12	7V4MR24V5P	IACT
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)	5WE8P977RQ	IACT
WHEAT GERM OIL	14C97E680P	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
DIMETHICONOL (41 MPA.S)	343C7U75XW	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT

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 8 · 475 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CETEARETH-12	CETEARETH-12	7V4MR24V5P	AEROSOL, FOAM / TOPICAL		200 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
469199f3-6194-4eda-8351-c99130f06299			ff3ef5f7-4846-48c6-aebc-26723f7f2320	2012-06-07	Warnings	Exact identifier spl id: 469199f3-6194-4eda-8351-c99130f06299 spl set id: ff3ef5f7-4846-48c6-aebc-26723f7f2320

Reported adverse events (FAERS/openFDA)#

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