Label: AMERICAN CREW ACUMEN MULTI DEFENSE MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10967-659-17 - Packager: Revlon Consumer Products Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 14, 2020
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- Drug Facts
- Purpose
- Uses
- Warnings
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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
- Label
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INGREDIENTS AND APPEARANCE
AMERICAN CREW ACUMEN MULTI DEFENSE MOISTURIZING SUNSCREEN
avobenzone, homosalate, octisalate lotionProduct 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)