SkinDog

Manufacturer: SkinDog, LLC
Effective date: 2012-01-05
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:31:04

Label at a glance#

ProductSkinDog

Active ingredientAvobenzone, Homosalate, Oxybenzone, Octisalate, Octocrylene

Label structure9 sections

Indications and uses

High UVB sunburn/UVA protection for skin highly sensitive to sunburn retains SPF after 80 minutes of activity

Dosage and administration

Apply liberally before sun exposure. Apply and reapply as directed to avoid lowering protection. Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every 2 hours. Children under 6 months; ask a doctor.

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Active Ingredients: Purpose
Avobenzone 3.0%...................................................................................................Sunscreen (A)
Octocrylene 4.0%...................................................................................................Sunscreen (B)
Oxybenzone 6.0%...................................................................................................Suncreeen (A)
Homosalate 15.0%.................................................................................................Sunscreen (B)
Octisalate 5.0%...................................................................................................Sunscreen (B)

Uses

OTC - PURPOSE SECTION

High UVB sunburn/UVA protection
for skin highly sensitive to sunburn
retains SPF after 80 minutes of activity

Warnings

WARNINGS SECTION

For External use only
UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally before sun exposure.
Apply and reapply as directed to avoid lowering protection.
Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every 2 hours.
Children under 6 months; ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua; Acrylates/C10-30 Alkyl Acrylate Crosspolymer; Sorbitol; Marshmellow Extract,; Ivy Extract; Cucumber Extract; Elder Flower; Arnica Extract; EDTA; Aloe Barbadensis Leaf Juice; Isopropyl Palmitate; Stearic Acid; PEG100 Stearate; Dimethicone; Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Tetrasodium EDTA; Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC - WHEN USING SECTION

When using this product keep out of eyes.

Rinse with water to remove.

May stain some fabrics

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if skin rash occurs.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42657-111-01	2019-11-13	C162847	48780-1	97449f38-ba0b-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42657-111-01	SkinDog	56.7 g in 1 TUBE	LOTION	56.7		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42657-111	SKINDOG (AVOBENZONE,OCTOCRYLENE,OXYBENZONE,HOMOSALATE,OCTISALATE) LOTION [SKINDOG, LLC]	5	Legacy NDC, 1 package rows	20120302_f63fe245-8396-477d-83af-66e5f4f7ceba.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	5
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	5
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	5
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	5
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	5
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	5
Homosalate	ACTIVE MOIETY	V06SV4M95S	5
Octisalate	ACTIVE MOIETY	4X49Y0596W	5
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	5
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	5
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	5
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	5
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	5
ALTHAEA OFFICINALIS ROOT	INACTIVE INGREDIENT	TRW2FUF47H	5
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	5
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	5
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	5
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	5
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	5
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	5
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	5
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	5
HEDERA HELIX LEAF	INACTIVE INGREDIENT	ZP9XFG71A7	5
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	5
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	5
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	5
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	5
Water	INACTIVE INGREDIENT	059QF0KO0R	5

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

SkinDog
Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate
Avobenzone
Homosalate
Oxybenzone
Octisalate
Octocrylene
Water
SORBITOL
Isopropyl Palmitate
C12-15 ALKYL BENZOATE
GLYCERYL DISTEARATE
STEARIC ACID
ALKYL (C12-15) BENZOATE
CETYL ALCOHOL
POLYOXYL 100 STEARATE
CARBOMER COPOLYMER TYPE A
ALOE VERA LEAF
Dimethicone
ALPHA-TOCOPHEROL ACETATE
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
CUCUMBER
HEDERA HELIX LEAF
ALTHAEA OFFICINALIS ROOT
EDETATE SODIUM
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42657-111	42657-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Avobenzone	G63QQF2NOX	ACTIB
Homosalate	V06SV4M95S	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Octisalate	4X49Y0596W	ACTIB
Octocrylene	5A68WGF6WM	ACTIB
Water	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
Isopropyl Palmitate	8CRQ2TH63M	IACT
C12-15 ALKYL BENZOATE	A9EJ3J61HQ	IACT
GLYCERYL DISTEARATE	73071MW2KM	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
CETYL ALCOHOL	936JST6JCN	IACT
POLYOXYL 100 STEARATE	YD01N1999R	IACT
CARBOMER COPOLYMER TYPE A	71DD5V995L	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
Dimethicone	92RU3N3Y1O	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
CUCUMBER	YY7C30VXJT	IACT
HEDERA HELIX LEAF	ZP9XFG71A7	IACT
ALTHAEA OFFICINALIS ROOT	TRW2FUF47H	IACT
EDETATE SODIUM	MP1J8420LU	IACT
TROLAMINE	9O3K93S3TK	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 3 · 160 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION, SOLUTION / INTRAVENOUS	0.04 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / OPHTHALMIC	0.1 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	TABLET / ORAL	5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	EMULSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	POWDER / TOPICAL	0.02 mg/mg		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYOXYL 100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERYL DISTEARATE	GLYCERYL DISTEARATE	73071MW2KM	CAPSULE, EXTENDED RELEASE / ORAL	39.2 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	LOTION / TOPICAL		71 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAMUSCULAR	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	GEL / TOPICAL	2 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	SUSPENSION / ORAL		20 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
GLYCERYL DISTEARATE	GLYCERYL DISTEARATE	73071MW2KM	TABLET / ORAL		100 mg	Exact identifier — unii candidate 4 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
d7589450-bec8-4796-bc91-aa096017870e			f63fe245-8396-477d-83af-66e5f4f7ceba	2012-01-05	Warnings	Exact identifier spl id: d7589450-bec8-4796-bc91-aa096017870e spl set id: f63fe245-8396-477d-83af-66e5f4f7ceba

Reported adverse events (FAERS/openFDA)#

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