FDA.reportPublic FDA data

Scout SPF-50

Manufacturer
MJ Products Association, LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:45:52

Label at a glance#

ProductScout SPF-50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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. REAPPLY: Al least every two-hours. Immediately after swimming, sweating or towel drying. : Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: SUN PROTECTION MEASURES Limit ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17.00%

Titanium Dioxide 6.00%

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 consult physician

OTC - STOP USE SECTION

if irritation or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure. REAPPLY:
  • Al least every two-hours.
  • Immediately after swimming, sweating or towel drying. : Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: SUN PROTECTION MEASURES
  • Limit time in the sun, especially between 10am and 2pm.
  • Wear long sleeve shirts, pants hats and sunglasses.
  • For children under 6 months, consult a physician.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cetearyl Olivate, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocamidopropyl Betaine, Cocos Nucifera (Coconut) Oil, Cymbopogon Nardus (Citronella) Oil, Dimethicone, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Isohexadecane, Laminaria (Algae) Extract, Lecithin, Mentha Piperita (Peppermint) Oil, Niacin, Parfum (Fragrance), Petrolatum, Polysorbate-20, Polysorbate-80, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Olivate, Styrene/Acrylates Copolymer, Thuja Occidentalis (Cedar) Leaf Oil, Tocopherol Acetate (Vitamin E), Vitis Vinifera (grape) Seed Extract, Xanthan Gum, Zemea (Corn) Propanediol.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Contact us directly at 1-888-601-0441

Distr. by/par: Sunshine & Glitter

MJ Products Association LLC

9750 NW 17th Street,  Miami, FL 33172

www.sunshineglitter.com

All Rights Reserved.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ScoutScout

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72085-15172085-151-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLAMIDE20R035KLCIIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETEARYL OLIVATE58B69Q84JOIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCONUT OILQ9L0O73W7LIACT
CITRONELLA OILQYO8Q067D0IACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SOYBEAN OIL241ATL177AIACT
ISOHEXADECANE918X1OUF1EIACT
PEPPERMINT OILAV092KU4JHIACT
NIACIN2679MF687AIACT
PETROLATUM4T6H12BN9UIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
SORBITAN OLIVATEMDL271E3GRIACT
STYRENE44LJ2U959VIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
29224f17-0aad-5ae2-e063-6394a90ab7ee147d5fe4-2a0c-4a9c-9dac-fd2ba0c764632024-12-13WarningsExact identifier
spl id: 29224f17-0aad-5ae2-e063-6394a90ab7ee
spl set id: 147d5fe4-2a0c-4a9c-9dac-fd2ba0c76463

Reported adverse events (FAERS/openFDA)#

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