FLESH HYDRATING SPF SERUM- avobenzone, homosalate, octisalate lotion
Revlon Consumer Products Corporation

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.

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Flesh Hydrating SPF Serum

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

Flesh SPF serum

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Revlon Consumer Products Corporation (788820165)

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