FDA.reportPublic FDA data

Sun-Defying Sunscreen Oil Broad Spectrum SPF 50

Manufacturer
TAYLOR JAMES, LTD. | Cosway Company Inc
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:33:26

Label at a glance#

ProductSun-Defying Sunscreen Oil Broad Spectrum SPF 50 Supergoop
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 15% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 7% Sunscreen

Octinoxate 7.5 % Sunscreen

OTC - PURPOSE SECTION

Uses
· helps prevent sunburn
· If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions
· Apply liberally 15 minutes before sun exposure
· Use a water resistant sunscreen if swimming or sweating

· Reapply at least every 2 hours

· Children under 6 months: Ask a doctor
· Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Octyl Dodecanol, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, SD Alcohol 40-B, Ethylenediamine/Hydrogenated Dimer Dilinoleate Copolymer Bis-Di-C14-18 Alkyl Amide, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Alaria Esculenta Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocotrienol, Argania Spinosa Kernel Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Punica Granatum Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Tangerina (Tangerine) Peel Extract, Citrus Limon (Lemon) Peel Extract, Calendula Officinalis Flower Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SecondarySecondary

Supergoop!

Sun-Defying Sunscreen oil with Meadowfoam

Broad Spectrum SPF 50

5 Fl. Oz. / 148 ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-125-022022-01-28C16284748780-1d6a99b39-7f83-a426-e053-dadaa90af4c2Sun-Defying Sunscreen Oil
75936-125-042022-01-28C16284748780-1d6a99b39-7f83-a426-e053-dadaa90af4c2Sun-Defying Sunscreen Oil
75936-125-062022-01-28C16284748780-1d6a99b39-7f83-a426-e053-dadaa90af4c2Sun-Defying Sunscreen Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-125-01Sun-Defying Sunscreen Oil Broad Spectrum SPF 50Supergoop148 mL in 1 BOTTLE, SPRAYOIL1487
75936-125-02Sun-Defying Sunscreen Oil Broad Spectrum SPF 50Supergoop1 in 1 BOXOIL17
75936-125-03Sun-Defying Sunscreen Oil Broad Spectrum SPF 50Supergoop30 mL in 1 BOTTLEOIL307
75936-125-04Sun-Defying Sunscreen Oil Broad Spectrum SPF 50Supergoop1 in 1 BOXOIL17
75936-125-05Sun-Defying Sunscreen Oil Broad Spectrum SPF 50Supergoop10 mL in 1 BOTTLEOIL107
75936-125-06Sun-Defying Sunscreen Oil Broad Spectrum SPF 50Supergoop1 in 1 BOXOIL17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-125SUN-DEFYING SUNSCREEN OIL BROAD SPECTRUM SPF 50 SUPERGOOP (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE) OIL [TAYLOR JAMES, LTD.]7Legacy NDC, 6 package rows20201113_529db87e-822f-4331-a1df-f72f53fa7d91.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX4
HOMOSALATEACTIVE INGREDIENTV06SV4M95S4
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD514
OCTISALATEACTIVE INGREDIENT4X49Y0596W4
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM4
AVOBENZONEACTIVE MOIETYG63QQF2NOX4
HOMOSALATEACTIVE MOIETYV06SV4M95S4
OCTINOXATEACTIVE MOIETY4Y5P7MUD514
OCTISALATEACTIVE MOIETY4X49Y0596W4
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM4
ALARIA ESCULENTAINACTIVE INGREDIENTEJ9JK8J58D4
ARGAN OILINACTIVE INGREDIENT4V59G5UW9X4
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ4
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD4
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L4
DIISOPROPYL SEBACATEINACTIVE INGREDIENTJ8T3X564IH4
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGG4
GRAPEFRUIT PEELINACTIVE INGREDIENT3582N05Q444
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XC4
LAURYL LACTATEINACTIVE INGREDIENTG5SU0BFK7O4
LEMON PEELINACTIVE INGREDIENT72O054U6284
MEADOWFOAM SEED OILINACTIVE INGREDIENT412ZHA4T4Y4
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U4
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y4
ORANGE PEELINACTIVE INGREDIENTTI9T76XD444
POMEGRANATEINACTIVE INGREDIENT56687D1Z4D4
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y4
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI4
TANGERINE PEELINACTIVE INGREDIENTJU3D4140574
TOCOTRIENOLSINACTIVE INGREDIENTKP2MW85SSQ4

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75936-12575936-125-01, 75936-125-02, 75936-125-03, 75936-125-04, 75936-125-05, 75936-125-06

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
NameUNIIKind
OCTYLDODECANOL461N1O614YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
LAURYL LACTATEG5SU0BFK7OIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
GRAPE SEED OIL930MLC8XGGIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOTRIENOLSKP2MW85SSQIACT
ARGAN OIL4V59G5UW9XIACT
COCONUT OILQ9L0O73W7LIACT
SHEA BUTTERK49155WL9YIACT
POMEGRANATE56687D1Z4DIACT
GRAPEFRUIT PEEL3582N05Q44IACT
ORANGE PEELTI9T76XD44IACT
TANGERINE PEELJU3D414057IACT
LEMON PEEL72O054U628IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
OCTYLDODECANOLOCTYLDODECANOL461N1O614YSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
LAURYL LACTATELAURYL LACTATEG5SU0BFK7OFILM, EXTENDED RELEASE / TRANSDERMAL12 mgExact identifier — unii candidate
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii candidate
9 equally ranked IID candidates
ORANGE PEELORANGE PEELTI9T76XD44SYRUP / ORALNAExact identifier — unii candidate
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YFILM / TRANSDERMAL32.44 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
OCTYLDODECANOLOCTYLDODECANOL461N1O614YSYSTEM / TRANSDERMAL4.05 mgExact identifier — unii candidate
9 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YGEL / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YLOTION / TOPICAL714 mgExact identifier — unii candidate
9 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YFILM, EXTENDED RELEASE / TRANSDERMAL253.4 mgExact identifier — unii candidate
9 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b3ef6a00-1d83-3b97-e053-2995a90a56fe529db87e-822f-4331-a1df-f72f53fa7d912020-11-12WarningsExact identifier
spl id: b3ef6a00-1d83-3b97-e053-2995a90a56fe
spl set id: 529db87e-822f-4331-a1df-f72f53fa7d91

Reported adverse events (FAERS/openFDA)#

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