EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30

Manufacturer
Extra Shade, LLC | Columbia Cosmetics Manufacturing, Inc.
Effective date
2025-03-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:57:23

Label at a glance#

ProductEXTRASHADE Daily Defense Hydrating Sunscreen SPF 30
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure17 sections

Indications and 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

Dosage and administration

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit tim...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose
Avobenzone 3.0%
Octinoxate 7.5%Sunscreen } Sunscreen
Octisalate 5.0%
Oxybenzone 4.0%

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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 a 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 ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glyceryl Stearate, Ethylhexyl Methoxycrylene, Glycerin, Jojoba Esters, Dimethicone, VP/Eicosene Copolymer, Cetearyl Alcohol, Cetyl Dimethicone, Potassium Cetyl Phosphate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Tocopheryl Acetate, Tertrahexyldecyl Ascorbate, Sodium Hyaluronate, Hydroxyethylcellulose, Hexylene Glycol, Punica Granatum Quillaja (Pomegranate) Extract, Cocos Nucifera (Coconut) Extract, Hedychium Coronarium Root (White Ginger) Extract, Actinidia Chinensis (Kiwi Fruit) Extract, Hibiscus Rosa Sinensis Extract, Passion Flora Incarnata (Passion Flower) Extract, Plantago Major Leaf (Plantain) Extract, Saponaria Bark (Soap Bark) Extract

Other information

OTHER SAFETY INFORMATION

• protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-637-5724

Purpose

OTC - PURPOSE SECTION

Sunscreen

Description

DESCRIPTION SECTION

EXTRASHADE SUN  PROTECTION FOR RICH COMPLEXIONS BROAD SPECTRUM SPF 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRASHADE SUN PROTECTION FOR RICH COMPLEXIONS  BROAD SPECTRUM SPF 30  DAILY DEFENSE HYDRATING SUNSCREEN LOTION  WATER RESISTANT (80 MINUTES) • PABA FREE  FRAGRANCE FREE • OIL FREE • DYE FREE  FACE AND BODY  PROTECTION FOR ACTIVE LIFESTYLE  4.0 Fl Oz (120ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

Extra Shade 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Extra Shade 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42338-001-04EXTRASHADE Daily Defense Hydrating Sunscreen SPF 301 in 1 CARTONLOTION14
42338-001-04EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30120 mL in 1 BOTTLELOTION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42338-001EXTRASHADE DAILY DEFENSE HYDRATING SUNSCREEN SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [EXTRA SHADE, LLC]4Current NDC, Legacy NDC, 2 package rows20250321_d197dfe3-c754-4a3d-9edd-335f3fce105c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
COCONUTINACTIVE INGREDIENT3RT3536DHY1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HEDYCHIUM CORONARIUM ROOTINACTIVE INGREDIENT92A6N0IQN91
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
HIBISCUS ROSA-SINENSIS FLOWERING TOPINACTIVE INGREDIENTX9SED658191
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)INACTIVE INGREDIENT8136Y38GY51
KIWI FRUITINACTIVE INGREDIENT71ES77LGJC1
PASSIFLORA EDULIS FLOWERINACTIVE INGREDIENTSY49TH8VUA1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PLANTAGO MAJOR LEAFINACTIVE INGREDIENT7DC28K241X1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT1
SAPONARIA OFFICINALIS ROOTINACTIVE INGREDIENTRI2K1BMA8B1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42338-00142338-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SYRUP / ORAL100 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5FILM, SOLUBLE / BUCCAL161 mgExact identifier — unii candidate
18 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SUSPENSION / ORAL1200 mgExact identifier — unii candidate
18 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5FILM / BUCCAL55 mgExact identifier — unii candidate
18 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, EXTENDED RELEASE / ORAL150 mgExact identifier — unii candidate
18 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5CAPSULE / ORAL20 mgExact identifier — unii candidate
18 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, EXTENDED RELEASE / ORAL150 mgExact identifier — unii candidate
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route
8 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii+route
8 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SYRUP / ORAL100 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5FILM / BUCCAL55 mgExact identifier — unii candidate
18 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route
8 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii+route
8 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SOLUTION / ORAL1867 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SUSPENSION / ORAL1200 mgExact identifier — unii candidate
18 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5CAPSULE / ORAL20 mgExact identifier — unii candidate
18 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5SOLUTION / ORAL1867 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S FOR 5% AQUEOUS SOLUTION)HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5FILM, SOLUBLE / BUCCAL161 mgExact identifier — unii candidate
18 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route
8 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 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
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEExtra Shade, LLCd197dfe3-c754-4a3d-9edd-335f3fce105c2025-03-18WarningsExact identifier
ndc (package): 42338-001-04
ndc (product): 42338-001
ndc11 (package): 42338000104
spl id: 30a652e0-6e3b-e676-e063-6294a90a0434
spl set id: d197dfe3-c754-4a3d-9edd-335f3fce105c

Reported adverse events (FAERS/openFDA)#

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