SOFT DERM INTENSIVE DEFENSE 8 SPF

Manufacturer: LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA
Effective date: 2011-06-15
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:28:17

Label at a glance#

ProductSOFT DERM INTENSIVE DEFENSE 8 SPF

Active ingredientOCTINOXATE, TITANIUM DIOXIDE

Label structure6 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

CALMING FACIAL EMULSION DAY

Balanced facial emulsion. Specifically created for the care of sensitive skin, with effects that are relaxing, cleaning, restoring, and protective.

INSTRUCTIONS FOR USE SECTION

Directions: After cleansing and toning the skin, gently massage into the skin until fully absorbed.

WARNINGS SECTION

Warnings: For external use only. Keep out of reach of children. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear.

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

OCTINOXATE 20% - sunscreen

TITANIUM DIOXIDE 14% - sunscreen

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: AQUA (THERMAL WATER), ICTYLDODECYL MYRISTATE, PEG-6 STEARATE, GLYCERIN, C12-15 ALKYL BENZOATE, CETYL ALCOHOL, DIMETHICONE, ALOE BARBADENSIS GEL 10:1, CAPPARIS SPINOSA FRUIT EXTRACT, HYDROLYZED ENTEROMORPHA COMPRESSA EXTRACT, CETETH-20, GLYCERYL STEARATE, STEARETH-20, XANTUAN GUM, ALLANTOIN, BUTYLENE GLYCOL, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINUM OXIDE, DISODIUM EDTA, PHENOXYETANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, DIMENTICONE CROSSPOLYMER, BHT, PERFUM.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75870-002-02	2019-10-29	C162847	48780-1	960f7f55-c572-8e05-e053-dbdaa90a074a	SOFT DERM INTENSIVE DEFENSE 8 SPF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75870-002-01	SOFT DERM INTENSIVE DEFENSE 8 SPF	50 mL in 1 TUBE	CREAM	50		4
75870-002-02	SOFT DERM INTENSIVE DEFENSE 8 SPF	1 in 1 CARTON	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75870-002	SOFT DERM INTENSIVE DEFENSE 8 SPF (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA]	4	Legacy NDC, 2 package rows	20110615_a4b9580d-f44d-4fa6-ac59-95da3965326f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	4
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	4
TITANIUM	ACTIVE MOIETY	D1JT611TNE	4
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	4
ALUMINUM STEARATE	INACTIVE INGREDIENT	U6XF9NP8HM	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	4
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	4
CAPER BERRY	INACTIVE INGREDIENT	7G4C45EE8C	4
CAPSOSIPHON FULVESCENS	INACTIVE INGREDIENT	C59NK6GFJH	4
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	4
HYDROXYSTEARIC ACID	INACTIVE INGREDIENT	933ANU3H2S	4
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
OCTYLDODECYL MYRISTATE	INACTIVE INGREDIENT	S013N99GR8	4
PEG-6 STEARATE	INACTIVE INGREDIENT	8LQC57C6B0	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
STEARETH-20	INACTIVE INGREDIENT	L0Q8IK9E08	4
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW)	INACTIVE INGREDIENT	Q04O53779D	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	4

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

SOFT DERM INTENSIVE DEFENSE 8 SPF
OCTINOXATE, TITANIUM DIOXIDE
OCTINOXATE
TITANIUM DIOXIDE
TITANIUM
OCTYLDODECYL MYRISTATE
PEG-6 STEARATE
GLYCERIN
ALKYL (C12-15) BENZOATE
CETYL ALCOHOL
DIMETHICONE
ALOE VERA LEAF
CAPER BERRY
CAPSOSIPHON FULVESCENS
CETETH-20
GLYCERYL MONOSTEARATE
STEARETH-20
XANTHAN GUM
ALLANTOIN
BUTYLENE GLYCOL
ALUMINUM STEARATE
HYDROXYSTEARIC ACID
ALUMINUM OXIDE
EDETATE DISODIUM
PHENOXYETHANOL
METHYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
BUTYLATED HYDROXYTOLUENE
WATER
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75870-002	75870-002-01, 75870-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
OCTYLDODECYL MYRISTATE	S013N99GR8	IACT
PEG-6 STEARATE	8LQC57C6B0	IACT
GLYCERIN	PDC6A3C0OX	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DIMETHICONE	92RU3N3Y1O	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CAPER BERRY	7G4C45EE8C	IACT
CAPSOSIPHON FULVESCENS	C59NK6GFJH	IACT
CETETH-20	I835H2IHHX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
STEARETH-20	L0Q8IK9E08	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ALLANTOIN	344S277G0Z	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
ALUMINUM STEARATE	U6XF9NP8HM	IACT
HYDROXYSTEARIC ACID	933ANU3H2S	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ETHYLPARABEN	14255EXE39	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
WATER	059QF0KO0R	IACT
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW)	Q04O53779D	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 · 441 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		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	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		84 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 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
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		7 mg	Exact identifier — unii candidate 15 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	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 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
debf540c-ac04-4732-8ea1-9b1f1c2793e4			a4b9580d-f44d-4fa6-ac59-95da3965326f	2011-06-15	Warnings	Exact identifier spl id: debf540c-ac04-4732-8ea1-9b1f1c2793e4 spl set id: a4b9580d-f44d-4fa6-ac59-95da3965326f

Reported adverse events (FAERS/openFDA)#

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