FDA.reportPublic FDA data

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

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Octinoxate 3.0% Octisalate 2.0%

Purpose

Sunscreen

Uses

Uses

Helps prevent sunburn

Warnings

Warnings

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 And Dosage

Directions

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 Label Information

Other Information

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

Label Images#

OPDKTAN4Label
OPDKTAN4Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62802-600-082019-11-13C16284748780-197449f38-d10f-f6ea-e053-dbdaa90aa703DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62802-600-08OP Dark Formula Xtreme Tanning 4251 mL in 1 BOTTLELOTION2514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62802-600OP DARK FORMULA XTREME TANNING 4 (OCTINOXATE, OCTISALATE) LOTION [SUN & SKIN CARE RESEARCH, LLC]4Legacy NDC, 1 package rows20120522_13ecb810-e04b-4c38-bef0-e3f4f24de7be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD514
OCTISALATEACTIVE INGREDIENT4X49Y0596W4
OCTINOXATEACTIVE MOIETY4Y5P7MUD514
OCTISALATEACTIVE MOIETY4X49Y0596W4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV84
CANOLA OILINACTIVE INGREDIENT331KBJ17RK4
CARAMELINACTIVE INGREDIENTT9D99G2B1R4
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV364
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
ETHYLPARABENINACTIVE INGREDIENT14255EXE394
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
HYPROMELLOSE 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP354
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
POLYISOBUTYLENE (2300 MW)INACTIVE INGREDIENTDSQ2V1DD1K4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD564
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62802-60062802-600-08

Ingredients#

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CARAMELT9D99G2B1RIACT
CANOLA OIL331KBJ17RKIACT
OLIVE OIL6UYK2W1W1EIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SUNFLOWER OIL3W1JG795YIIACT
BUTYLPARABEN3QPI1U3FV8IACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Complete SPL Sections#

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

Source Document#

Source XML