FDA.reportPublic FDA data

Amercian Crew Acumen Multi Defense Moisturizing Sunscreen Lotion

Manufacturer
Revlon Consumer Products Corporation | Englewood Lab, Inc.
Effective date
2020-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:23

Label at a glance#

ProductAmerican Crew Acumen Multi Defense Moisturizing Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure7 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 - repply: - at least every 2 hours - use a water resistant sunscreen if swimming or sweating - sun protection measures. Spending time in the sun increases your risk of cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or higher and other sun protection measures including: - limit time in the sun, especially from 1...

Storage and handling

- Protect this product from excessive heat and direct sun - Store at room temperature

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

OTC - PURPOSE 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 on damaged or broken skin

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

- Stop use and ask a doctor is rash occurs.

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

Directions For Sunscreen Use

INSTRUCTIONS FOR USE SECTION

- apply liberally 15 minutes before sun exposure

- repply:

- at least every 2 hours

- use a water resistant sunscreen if swimming or sweating

- sun protection measures. Spending time in the sun increases your risk of cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or higher and other sun protection measures including:

- limit time in the sun, especially from 10 a.m. to 2p.m.

- wear long sleeve shirts, pants, hats and sunglasses

Storage

STORAGE AND HANDLING SECTION

- Protect this product from excessive heat and direct sun

- Store at room temperature

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

acumenacumen

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-659-172021-07-23C16284748780-1c7ccaba7-2847-fd44-e053-dadaa90aa01bAmercian Crew Acumen Multi Defense Moisturizing Sunscreen Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-659-17American Crew Acumen Multi Defense Moisturizing Sunscreen50 mL in 1 PACKAGELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-659AMERICAN CREW ACUMEN MULTI DEFENSE MOISTURIZING SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [REVLON CONSUMER PRODUCTS CORPORATION]1Legacy NDC, 1 package rows20200123_9c1c6aa2-f92c-3ba3-e053-2995a90a323d.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-65910967-659-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
LAURETH-7Z95S6G8201IACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
GINGERC5529G5JPQIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
HYALURONATE SODIUMYSE9PPT4THIACT
LINALOOL, (+)-F4VNO44C09IACT
PHENOXYETHANOLHIE492ZZ3TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S)LZ291VH90HIACT
CHLORPHENESINI670DAL4SZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CAPRYLYL GLYCOL00YIU5438UIACT

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
9c1c6aa2-f92d-3ba3-e053-2995a90a323d9c1c6aa2-f92c-3ba3-e053-2995a90a323d2020-01-14WarningsExact identifier
spl id: 9c1c6aa2-f92d-3ba3-e053-2995a90a323d
spl set id: 9c1c6aa2-f92c-3ba3-e053-2995a90a323d

Reported adverse events (FAERS/openFDA)#

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