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I.C. Industrial Sunscreen

I.C. Industrial Sunscreen

Approved
Approval ID

b89d687a-7b36-4643-9817-765d4710ca60

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

R & R Lotion, Inc

DUNS: 062979000

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ZINC OXIDE, OCTINOXATE, OXYBENZONE, and OCTISALATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59555-117
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC OXIDE, OCTINOXATE, OXYBENZONE, and OCTISALATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (19)

ZINC OXIDEActive
Quantity: 67.3 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIM
OCTINOXATEActive
Quantity: 57.5 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
OXYBENZONEActive
Quantity: 45 mg in 1 mL
Code: 95OOS7VE0Y
Classification: ACTIB
OCTISALATEActive
Quantity: 38.3 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
DIETHYLHEXYL ADIPATEInactive
Code: MBY1SL921L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 MONOSTEARATEInactive
Code: YD01N1999R
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
IMIDUREAInactive
Code: M629807ATL
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
OLETH-3 PHOSPHATEInactive
Code: 8Q0Z18J1VL
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

SPF 36

I.C.®
Industrial
Sunscreen

R&R LOTION
USA

Full Broad
Spectrum
8oz. (236ml) ℮

Principal Display Panel - 236 ml Bottle Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/15/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active Ingredients

Purpose

Zinc Oxide

6.73%

Sunscreen

Octinoxate

5.75%

Sunscreen

Benzophenone-3

4.50%

Sunscreen

Octisalate

3.83%

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove

Stop use and ask a doctor if a rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

Directions

  • apply liberally 15 minutes before sun exposure reapply:
    • after 80 minutes of swimming or sweating

    • immediately 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive Ingredients

DI Water, Ethylhexyl Stearate/Ethylhexyl Palmitate/Diethylhexy Adipate, Propylene Glycol, Glyceryl Stearate (and) PEG-100 Stearate, Cetearyl Alcohol (and) Cetearth-20 Xanthan Gum, Imidazolidinyl Urea, Methyl Paraben, Propyl Paraben, Oleth 3 Phosphate, Vitamin E

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/15/2025

Other Information

  • protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

Questions or Samples?

1-888-860-7424

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I.C. Industrial Sunscreen - FDA Drug Approval Details