Day in the sun kit

Manufacturer
THE WONDERFUL GROUP LLC
Effective date
2023-01-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:26

Label at a glance#

ProductDay in the sun kit
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure22 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 and evenly 15 minutes before sun exposure children under 6 months of age: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear lon...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0% Homosalate 8.0%
Octisalate 5.0% Octocrylene 8.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 on damaged or broken skin
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if irritation or rash develops
Keep out of reach of children. If product is swallowed, get medical attention or contact Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally and evenly 15 minutes before sun exposure
children under 6 months of age: 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses 
  • reapply at least every 2 hours 
  • use a water-resistant sunscreen if swimming or sweating

Other information

SPL UNCLASSIFIED SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Propylene Glycol, PEG-100 Stearate,VP/Eicosene Copolymer, Acrylates Copolymer, Steareth-20,Glyceryl Stearate, Steareth-2, Fragrance, Phenoxyethanol,Ethylhexylglycerin, Acrylates/C1 0-30 Alkyl Acrylate
Crosspolymer, Disodium EDTA, Sodium Hyaluronate,Sodium Hydroxide,fragrance

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00% Homosalate 9.0%
Octisalate 5.0% Octocrylene 9.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 on damaged or broken skin
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if irritation or rash develops
Keep out of reach of children. If a product is swallowed, get medical attention or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally and evenly 15 minutes before sun exposure
children under 6 months of age: 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses 
  • reapply at least every 2 hours 
  • use a water-resistant sunscreen if swimming or sweating

Other information

SPL UNCLASSIFIED SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Vilis Vinifara Seed Oil, Butyloctyl Salicylate, Cocos Nucifera Oil, Glyceryl Stearate, Butylene Glycol Dicaprylate/Dicaprate, Aloe Barbadensis Leaf Extract, VP/Eicosene Copolymer, Acrylates Copolymer, Cetearyl Alcohol,Steareth-20, Steareth-2, Fragrance, Trehalose, Sodium PCA,Prunus Persica(Peach)Resin ExTract, DendrobiumCandidum Stem Extract, Tremella Fuciformis Sporocarp Extract, Cistanche Deserticola Extract, Phenoxyethanol,Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate,TocopheryiAcetate,Sodium Hydroxide,fragrance

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0% Homosalate 8.0%
Octisalate 5.0% Octocrylene 8.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 on damaged or broken skin
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if irritation or rash develops
Keep out of reach of children. If product is swallowed, get medical attention or contact Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally and evenly 15 minutes before sun exposure
children under 6 months of age: 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses 
  • reapply at least every 2 hours 
  • use a water-resistant sunscreen if swimming or sweating

Other information

SPL UNCLASSIFIED SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Ceresine,Microcrystalline Wax, Hydrogenated Vegetable Oil,Hydrogenated Soybean Oil, Olea Europaea Fruit Oil,Butyrospermum Parkii Butter, VP/Eicosene Copolymer,fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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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
80782-001-012025-01-30C16284748780-12cef2736-5f18-d83d-e063-dadaa90ab31f2c8ab6f2-930e-47e4-946a-965df238e05e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80782-001-01Day in the sun kit1 in 1 KITKIT12
80782-002-01Day in the sun kit75 mL in 1 TUBELOTION75 mL8 g in 100mL2
80782-003-01Day in the sun kit50 mL in 1 JARCREAM50 mL9 g in 100mL2
80782-004-01Day in the sun kit4.5 g in 1 TUBEGEL4.5 g5 g in 100g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80782-001DAY IN THE SUN KIT (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) KIT [THE WONDERFUL GROUP LLC]2Legacy NDC, 4 package rows20230125_2c8ab6f2-930e-47e4-946a-965df238e05e.zip
80782-002DAY IN THE SUN KIT (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) KIT [THE WONDERFUL GROUP LLC]2Unmatched20230125_2c8ab6f2-930e-47e4-946a-965df238e05e.zip
80782-003DAY IN THE SUN KIT (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) KIT [THE WONDERFUL GROUP LLC]2Unmatched20230125_2c8ab6f2-930e-47e4-946a-965df238e05e.zip
80782-004DAY IN THE SUN KIT (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) KIT [THE WONDERFUL GROUP LLC]2Unmatched20230125_2c8ab6f2-930e-47e4-946a-965df238e05e.zip

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 61 matching rows.

Source Document#

Source XML

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
f306dd76-d266-ff95-e053-2a95a90a8a0c2c8ab6f2-930e-47e4-946a-965df238e05e2023-01-24WarningsExact identifier
spl id: f306dd76-d266-ff95-e053-2a95a90a8a0c
spl set id: 2c8ab6f2-930e-47e4-946a-965df238e05e

Reported adverse events (FAERS/openFDA)#

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