FDA.reportPublic FDA data

NO-AD Broad Spectrum SPF 50 Sunscreen Lotion

Manufacturer
Prime Enterprises
Effective date
2024-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:03:42

Label at a glance#

ProductNO-AD Broad Spectrum SPF 50
Active ingredientOCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE
Label structure8 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 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 between 10 am - 2 pm wear long-sleeved shi...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

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

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

  • apply liberally 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 between 10 am - 2 pm
  • wear long-sleeved shirts, pants, hats and sunglasses
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics/materials or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Cocos Nucifera (Coconut) Oil, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

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 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-065758443-0657-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
CARBOMER 9804Q93RCW27EIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AVOBENZONEG63QQF2NOXACTIB
COCONUT OILQ9L0O73W7LIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LOW DENSITY POLYETHYLENEJ245LN42AIIACT
SODIUM HYDROXIDE55X04QC32IIACT
COCOA BUTTER512OYT1CRRIACT
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT

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
17cabd33-db84-712a-e063-6394a90a0ffb17cabd33-db83-712a-e063-6394a90a0ffb2024-05-06WarningsExact identifier
spl id: 17cabd33-db84-712a-e063-6394a90a0ffb
spl set id: 17cabd33-db83-712a-e063-6394a90a0ffb

Reported adverse events (FAERS/openFDA)#

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