Naked Sundays

Manufacturer
Prime Enterprises
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:56:25

Label at a glance#

ProductNaked Sundays SPF 50 Broad Spectrum
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTISALATE, HOMOSALATE
Label structure9 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

shake well before use Avoid eye area use as top up sunscreen only hold 8-10" away from your body and spray liberally & evenly until skin feels moist 15 minutes before sun exposure Do not spray directly on to face. Make sure no spots are missed by spraying onto hands and applying to face Do not apply in windy conditions Use in a well-ventilated area Avoid inhalation Use a water resistant sunscreen if swimming or sw...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

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
  • 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 help prevent sunburn, not skin cancer or early skin aging
  • Flammable: Keep away from flames and sparks. Wait 5/10 minutes after application before approaching a source of heat or flame, or before smoking
  • Use a water-resistant sunscreen if swimming or sweating

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

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • Avoid eye area
  • use as top up sunscreen only
  • hold 8-10" away from your body and spray liberally & evenly until skin feels moist 15 minutes before sun exposure
  • Do not spray directly on to face. Make sure no spots are missed by spraying onto hands and applying to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area
  • Avoid inhalation
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply immediately after towel drying
  • Reapply at least every 2 hours
  • 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 10am - 2pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethanol, Citrullus Lanatus Seed Oil, Hyaluronic Acid, Kakadu Plum, Tocopheryl Acetate, Fragrance

Other Information

OTHER SAFETY INFORMATION

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

Questions?

OTC - QUESTIONS SECTION

info@nakedsundays.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display FrontPrincipal Display FrontPrincipal Display BackPrincipal Display Back

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-066158443-0661-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
1e91a856-32d0-9843-e063-6394a90ae1401e91a856-32cf-9843-e063-6394a90ae1402024-07-31WarningsExact identifier
spl id: 1e91a856-32d0-9843-e063-6394a90ae140
spl set id: 1e91a856-32cf-9843-e063-6394a90ae140

Reported adverse events (FAERS/openFDA)#

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