Skin Care Prescription

Manufacturer: Skin Care Physicians, Inc.
Effective date: 2010-10-18
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:26:21

Label at a glance#

ProductSkin Care Prescription

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; Tocopheryl Acetate; Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; DMDM Hydantoim; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Acrylates/C12-22 Alkylmethacrylates Copolymer; Retinyl Palmitate

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52347-111-01	2019-10-29	C162847	48780-1	960f7f55-c1ca-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	2
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	2
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	2
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	2
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	2
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	2
Homosalate	ACTIVE MOIETY	V06SV4M95S	2
Octisalate	ACTIVE MOIETY	4X49Y0596W	2
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	2
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	2
ACAI	INACTIVE INGREDIENT	46AM2VJ0AW	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	2
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	2
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	2
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
CRANBERRY	INACTIVE INGREDIENT	0MVO31Q3QS	2
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	2
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	2
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	2
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	2
PUNICA GRANATUM ROOT BARK	INACTIVE INGREDIENT	CLV24I3T1D	2
SAMBUCUS NIGRA FLOWER	INACTIVE INGREDIENT	07V4DX094T	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Skin Care Prescription
Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate
Avobenzone
Homosalate
Oxybenzone
Octisalate
Octocrylene
Water
SORBITOL
Isopropyl Palmitate
C12-15 ALKYL BENZOATE
GLYCERYL DISTEARATE
STEARIC ACID
METHACRYLIC ACID
CETYL ALCOHOL
POLYOXYL 100 STEARATE
CARBOMER COPOLYMER TYPE A
ALOE VERA LEAF
Dimethicone
ALPHA-TOCOPHEROL ACETATE
Ascorbyl Palmitate
VITAMIN A PALMITATE
PUNICA GRANATUM ROOT BARK
ACAI
CRANBERRY
CUCUMBER
SAMBUCUS NIGRA FLOWER
ARNICA MONTANA
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
DMDM HYDANTOIN
EDETIC ACID
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52347-111	52347-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
METHACRYLIC ACID	1CS02G8656	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
Ascorbyl Palmitate	QN83US2B0N	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
PUNICA GRANATUM ROOT BARK	CLV24I3T1D	IACT
ACAI	46AM2VJ0AW	IACT
CRANBERRY	0MVO31Q3QS	IACT
CUCUMBER	YY7C30VXJT	IACT
SAMBUCUS NIGRA FLOWER	07V4DX094T	IACT
ARNICA MONTANA	O80TY208ZW	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
EDETIC ACID	9G34HU7RV0	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 · 158 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	SUPPOSITORY / RECTAL		16 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	CREAM / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SUPPOSITORY / RECTAL		7 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 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
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		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
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYOXYL 100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL DISTEARATE	GLYCERYL DISTEARATE	73071MW2KM	TABLET, EXTENDED RELEASE / ORAL		13 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POLYOXYL 100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	CAPSULE / ORAL	12 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 13 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
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 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	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 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
4d08bcae-5846-41a6-8136-651da8e1c582			8b31ca87-c814-478e-909d-31332233f74d	2010-10-18	Warnings	Exact identifier spl id: 4d08bcae-5846-41a6-8136-651da8e1c582 spl set id: 8b31ca87-c814-478e-909d-31332233f74d

Reported adverse events (FAERS/openFDA)#

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