AMERICAN CREW ACUMEN MULTI DEFENSE MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate lotion

American Crew Acumen Multi Defense Moisturizing Sunscreen by

Drug Labeling and Warnings

American Crew Acumen Multi Defense Moisturizing Sunscreen by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corporation, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Purpose

Sunscreen

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

- 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

- 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

- Protect this product from excessive heat and direct sun

- Store at room temperature

Label

INGREDIENTS AND APPEARANCE

AMERICAN CREW ACUMEN MULTI DEFENSE MOISTURIZING SUNSCREEN 
avobenzone, homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-659
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
LAURETH-7 (UNII: Z95S6G8201)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
GINGER (UNII: C5529G5JPQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LINALOOL, (+)- (UNII: F4VNO44C09)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-659-17	50 mL in 1 PACKAGE; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/02/2020

Labeler - Revlon Consumer Products Corporation (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(10967-659)