FDA.reportPublic FDA data

30 SPF

Manufacturer
Shalom International Corp | Empack Spraytech Inc
Effective date
2021-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:24:18

Label at a glance#

Product30 SPF Jack Nicklaus
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE
Label structure9 sections

Dosage and administration

Adults, adolescents and children over 6 months of age •Spray generously and spread evenly by hand 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. • Do not spray directly onto face. Spray on hands, thenapply to face. Do not apply in windy conditions • Use in a well-ventilated area.•Avoid inhaling or exposing others to spray. Reapply: after 80 minutes of swimming or sweating immediat...

Label contents#

Full prescribing information#

Active Ingredients (w/w )

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Homosalate 15%

Octisalate 5%

Oxybenzone 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other skin protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.Do not place in hot water or near radiator, stove or other sources of heat.

Do not puncture or incinerate container or store at temperature above 50°C. Contents under pressure.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults, adolescents and children over 6 months of age •Spray generously and spread evenly by hand 15 minutes before sun exposure.
  • Hold container 4 to 6 inches from skin to apply. • Do not spray directly onto face. Spray on hands, thenapply to face.
  • Do not apply in windy conditions • Use in a well-ventilated area.•Avoid inhaling or exposing others to spray.
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun • Store at room temperature 59-86°F. May stain surfaces and fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/ Octylacrylamide Copolymer, Alcohol Denat., Aloe Barbadensis Leaf Juice, Cocos Nucifera (coconut) oil, Diethylhexyl 2,6- Naphthalate, Glycerin, Mineral Oil, Fragrance (Parfum).

Questions?

OTC - QUESTIONS SECTION

1-866-923-2665

Manufactured in Canada by/ Fabriqué au Canada par: Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, L6T 4H6

UPC Please recycle (+ logo) Lot # and Expiry Date jet printed on the bottom of the aerosol can

Principal Display Panel - 30 SPF SUNSCREEN SPRAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 SPF SUNSCREEN SPRAY

BROAD SPECTRUM SPF 30

UVA/UVB PROTECTION

Water/ Sweat Resistant (80 MINUTES)

Net Content 177 ml/ 16 fl. oz   (159 g)

image descriptionimage description

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
73025-07073025-070-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
ALCOHOL3K9958V90MIACT
COCONUT OILQ9L0O73W7LIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB

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
d2927b7f-2867-7d96-e053-2a95a90ac18f1f35b666-d68a-4334-a440-45a197e692b02021-12-07WarningsExact identifier
spl id: d2927b7f-2867-7d96-e053-2a95a90ac18f
spl set id: 1f35b666-d68a-4334-a440-45a197e692b0

Reported adverse events (FAERS/openFDA)#

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