OP Dark Formula Xtreme Tanning 4

Manufacturer: Sun & Skin Care Research, LLC
Effective date: 2012-05-21
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:31:59

Label at a glance#

ProductOP Dark Formula Xtreme Tanning 4

Active ingredientOCTINOXATE, OCTISALATE

Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

apply evenly and liberally to all exposed areas 15 minutes before sun exposure. Ensure skin is completely covered with product. reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours children under 6 months: Ask a doctor

Storage and handling

protect this product from excessive heat and direct sun for use on skin only avoid contact with fabric

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.0%
Octisalate 2.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or call a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply evenly and liberally to all exposed areas 15 minutes before sun exposure. Ensure skin is completely covered with product.
reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
children under 6 months: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun
for use on skin only
avoid contact with fabric

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62802-600-08	2019-11-13	C162847	48780-1	97449f38-d10f-f6ea-e053-dbdaa90aa703	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62802-600-08	OP Dark Formula Xtreme Tanning 4	251 mL in 1 BOTTLE	LOTION	251		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62802-600	OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]	4	Legacy NDC, 1 package rows	20120522_13ecb810-e04b-4c38-bef0-e3f4f24de7be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	4
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	4
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	4
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	4
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	4
CANOLA OIL	INACTIVE INGREDIENT	331KBJ17RK	4
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	4
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	4
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	4
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	4
POLYISOBUTYLENE (2300 MW)	INACTIVE INGREDIENT	DSQ2V1DD1K	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	4
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

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

OP Dark Formula Xtreme Tanning 4
octinoxate, octisalate
OCTINOXATE
OCTISALATE
ALOE VERA LEAF
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CARBOMER HOMOPOLYMER TYPE C
CARAMEL
CANOLA OIL
OLIVE OIL
VITAMIN A PALMITATE
ALPHA-TOCOPHEROL ACETATE
SUNFLOWER OIL
BUTYLPARABEN
EDETATE DISODIUM
ETHYLPARABEN
GLYCERIN
HYPROMELLOSE 2910 (4000 MPA.S)
ISOBUTYLPARABEN
METHYLPARABEN
PHENOXYETHANOL
POLYISOBUTYLENE (2300 MW)
PROPYLENE GLYCOL
PROPYLPARABEN
SORBITAN MONOOLEATE
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62802-600	62802-600-08

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
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	IACT
CARBOMER HOMOPOLYMER TYPE C	4Q93RCW27E	IACT
CARAMEL	T9D99G2B1R	IACT
CANOLA OIL	331KBJ17RK	IACT
OLIVE OIL	6UYK2W1W1E	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ETHYLPARABEN	14255EXE39	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYISOBUTYLENE (2300 MW)	DSQ2V1DD1K	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	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 9 · 496 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 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	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 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	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	SPRAY / TOPICAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TRANSDERMAL		150 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	FILM, EXTENDED RELEASE / TRANSDERMAL	38.9 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	OINTMENT, AUGMENTED / TOPICAL		23 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	SUPPOSITORY / RECTAL		390 mg	Exact identifier — unii candidate 16 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	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	TABLET, DELAYED RELEASE / ORAL	127.29 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	CAPSULE / ORAL		288 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		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
TROLAMINE	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 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	INJECTION / INTRAMUSCULAR		450 mg	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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 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
b9914b80-2352-42d3-899d-959ae2f5ef1e			13ecb810-e04b-4c38-bef0-e3f4f24de7be	2012-05-21	Warnings	Exact identifier spl id: b9914b80-2352-42d3-899d-959ae2f5ef1e spl set id: 13ecb810-e04b-4c38-bef0-e3f4f24de7be

Reported adverse events (FAERS/openFDA)#

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