Face Lotion with Sunscreen SPF 20

Manufacturer
Cremo company
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:40

Label at a glance#

ProductCremo Sunscreen
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Storage and handling

Other information Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on broken or damaged 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 rash occurs

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • Sun Protections 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 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

STORAGE AND HANDLING SECTION

Other information

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients Acrylamide/Sodium Acroylyldimethyl Taurate Copolymer, Aloe Vera Juice, Water (Aqua),Green Tea Extract, Carbomer, Cetyl Alcohol, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexylglycerin, Sunflower Oil, Isohexadecane, Phenoxyethanol, Polysorbate 20, Polysorbate-80, Propylene Glycol, Pomegranate Extract, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine

SPL UNCLASSIFIED SECTION

cremocompany.com

Distributed by Cremo Company LLC, Laguna Beach, CA 92651

(800) 853-1762 © 2019 Cremo Co. Not tested on Animals.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cremo®

Astonishingly Superior®

FACE LOTION WITH SUNSCREEN

PREVENTATIVE FORMULA

HYDRATES & NOURISHES WHILE PROTECTING SKIN FROM THE ELEMENTS

BROAD SPECTRUM SPF 20

MOISTURIZER + SUN PROTECTION

Essential skincare

2 FL OZ (59 mL)

111319_Cremo_Moisturizer111319_Cremo_Moisturizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71825-102-012022-01-28C16284748780-1d6a99b39-36bc-a426-e053-dadaa90af4c2Face Lotion with Sunscreen SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71825-102-01Cremo Sunscreen59 mL in 1 BOTTLE, PLASTICLOTION591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71825-102CREMO SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [CREMO COMPANY]1Legacy NDC, 1 package rows20200101_994a08c4-265e-a3a3-e053-2995a90a914e.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71825-10271825-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
994a08c4-2655-a3a3-e053-2995a90a914e994a08c4-265e-a3a3-e053-2995a90a914e2019-12-09WarningsExact identifier
spl id: 994a08c4-2655-a3a3-e053-2995a90a914e
spl set id: 994a08c4-265e-a3a3-e053-2995a90a914e

Reported adverse events (FAERS/openFDA)#

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