Industrial Strength Sunscreen

Manufacturer
R & R Lotion, Inc
Effective date
2020-08-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:36:58

Label at a glance#

ProductIndustrial Strength Sunscreen
Active ingredientZinc Oxide, Octinoxate, Octisalate, Oxybenzone
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 & early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediatly after towel drying every 2 hours 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 of 15 or higher and other sun protection measures including:   limit time in the sun, especial...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Octinoxate 5.9%Sunscreen
Octisalate 3.8%Sunscreen
Oxybenzone 4.7%Sunscreen
Zinc Oxide 6.4%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 & 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

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if a rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 reapply:
    • after 80 minutes of swimming or sweating
    • immediatly after towel drying
    • every 2 hours

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 of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10am-2pm
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified DI Water, Octyl Stearate/Octyl Palmitate/Dioctyl Adipate, Propylene Glycol, Glyceryl Stearate & Peg 100, Cetearyl Alcohol & Ceteareth 20, Xanthan Gum, Imidazolidinyl Urea, Methyl Paraben, Propyl Paraben, Crodafos N3N, and Vitamin E.

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions & Comments

OTC - QUESTIONS SECTION

1-888-860-7424

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WATER RESISTANCE
(80 MINUTES)

STRENGTH
INDUSTRIAL
SUNSCREEN

SPF 30
BROAD SPECTRUM

2 FL. OZ. (59ML) e

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-102-01Industrial Strength Sunscreen5 mL in 1 PACKETLOTION53
59555-102-03Industrial Strength Sunscreen50 mL in 1 BOTTLE, PUMPLOTION503
59555-102-04Industrial Strength Sunscreen59 mL in 1 BOTTLE, DISPENSINGLOTION593
59555-102-07Industrial Strength Sunscreen118 mL in 1 BOTTLE, DISPENSINGLOTION1183
59555-102-08Industrial Strength Sunscreen236 mL in 1 BOTTLE, DISPENSINGLOTION2363
59555-102-10Industrial Strength Sunscreen946 mL in 1 BOTTLE, PUMPLOTION9463
59555-102-11Industrial Strength Sunscreen3785 mL in 1 BOTTLE, PLASTICLOTION37853
59555-102-15Industrial Strength Sunscreen4 mL in 1 PACKETLOTION43
59555-102-16Industrial Strength Sunscreen4 mL in 1 PACKETLOTION43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-102INDUSTRIAL STRENGTH SUNSCREEN (ZINC OXIDE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [R & R LOTION, INC]3Legacy NDC, 9 package rows20210115_d2e6da66-9c6f-4c7e-b43d-3072e1c6444a.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
f68d426e-62ed-4474-b46b-76c23662b331d2e6da66-9c6f-4c7e-b43d-3072e1c6444a2020-08-05WarningsExact identifier
spl id: f68d426e-62ed-4474-b46b-76c23662b331
spl set id: d2e6da66-9c6f-4c7e-b43d-3072e1c6444a

Reported adverse events (FAERS/openFDA)#

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