DERMAPROT

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 22:32:42

Label at a glance#

ProductDERMAPROT HELIOPROT AB SPF 30

Active ingredientOCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE, OXYBENZONE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, BUTYL METHOXYDIBENZOYLMETHANE, BENZOPHENONE-3, are a set of physical and chemical filters that provide SPF 30

OTC - PURPOSE SECTION

Sunscreen lotion from wide spectrum sunscreen SPF 30

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Provides moderate protection against sun. This product is for topical application.

WARNINGS SECTION

Avoid the contact with eyes, rinse with water to remove.

Do not apply this product on under six months aged children

DOSAGE & ADMINISTRATION SECTION

Rub to cover the area to be protected and wait for its full absorption

INACTIVE INGREDIENT SECTION

Solar protector UVA UVB has an aqeous base where we deposited all the active ingredients to garantee a wide range of the sun protection; rehydrates the skin tissues maintining cellular bioactivity without the inconvenient of the oily foundations.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF THE CARTON LABEL IMAGE OF THE CARTON LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66854-026-01	2019-11-13	C162847	48780-1	97449f38-b831-f6ea-e053-dbdaa90aa703	DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30
66854-026-02	2019-11-13	C162847	48780-1	97449f38-b831-f6ea-e053-dbdaa90aa703	DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30
66854-026-03	2019-11-13	C162847	48780-1	97449f38-b831-f6ea-e053-dbdaa90aa703	DERMAPROT HELIOPROT LOCION ANTISOLAR SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-026-01	DERMAPROTHELIOPROT AB SPF 30	10 mL in 1 BOTTLE	LOTION	10	1
66854-026-02	DERMAPROTHELIOPROT AB SPF 30	45 mL in 1 BOTTLE	LOTION	45	1
66854-026-03	DERMAPROTHELIOPROT AB SPF 30	70 mL in 1 BOTTLE	LOTION	70	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-026	DERMAPROT HELIOPROT AB SPF 30 (OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE) LOTION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 3 package rows	20120809_1121cb01-8d2f-4b80-a86f-0f4b18ff34d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	1
CHAMOMILE FLOWER OIL	INACTIVE INGREDIENT	60F80Z61A9	1
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	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

Products#

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

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

DERMAPROT HELIOPROT AB SPF 30
OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE
OCTINOXATE
TITANIUM DIOXIDE
AVOBENZONE
OXYBENZONE
WATER
PROPYLENE GLYCOL
GLYCERIN
ALUMINUM OXIDE
DIMETHICONE
SILICON DIOXIDE
GLYCERYL MONOSTEARATE
ALOE VERA LEAF
CHAMOMILE
CETYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE, D-
OCTYLDODECANOL
DICAPRYLYL CARBONATE
MEDIUM-CHAIN TRIGLYCERIDES
POLYSORBATE 20
CETOSTEARYL ALCOHOL
SODIUM CETOSTEARYL SULFATE
CHAMOMILE FLOWER OIL
EDETATE DISODIUM
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66854-026	66854-026-01, 66854-026-02, 66854-026-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERIN	PDC6A3C0OX	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CHAMOMILE	FGL3685T2X	IACT
CETYL ALCOHOL	936JST6JCN	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
OCTYLDODECANOL	461N1O614Y	IACT
DICAPRYLYL CARBONATE	609A3V1SUA	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	IACT
CHAMOMILE FLOWER OIL	60F80Z61A9	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	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 10 · 569 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		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
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 9 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	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM, EXTENDED RELEASE / TRANSDERMAL	253.4 mg		Exact identifier — unii candidate 9 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 / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SOLUTION / ORAL		5566 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 2 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
3aa210bd-65ec-411f-9328-2dc7ae4cd504			1121cb01-8d2f-4b80-a86f-0f4b18ff34d6	2012-06-07	Warnings	Exact identifier spl id: 3aa210bd-65ec-411f-9328-2dc7ae4cd504 spl set id: 1121cb01-8d2f-4b80-a86f-0f4b18ff34d6

Reported adverse events (FAERS/openFDA)#

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