FLESH HYDRATING SPF SERUM- avobenzone, homosalate, octisalate lotion

Flesh Hydrating SPF Serum by

Drug Labeling and Warnings

Flesh Hydrating SPF Serum 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 submburn

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancerand early skin aging caused by the sun.

Warnings

- For external use only

- Do not use on danaged or broken skin

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

- Stop use and ask a doctor if rash occurs

- Keep out of reach of children. If swallowed get medical helpor contact a Poison Control Center right away.

Directions

- Apply liberally 15 minutes before sun exposure

- Use a water resistant sunscreen if swimming or sweating

- Reapply at least every 2 hours

Other Information

Protect this product from excessive heat and direct sun

Package

INGREDIENTS AND APPEARANCE

FLESH HYDRATING SPF SERUM 
avobenzone, homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-660
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
UREA (UNII: 8W8T17847W)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LINALOOL, (+)- (UNII: F4VNO44C09)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-660-01	30 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2020

Labeler - Revlon Consumer Products Corporation (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(10967-660)