REVLON KISS BALM SPF 20- avobenzone, benzophenone-3, octinoxate stick
Revlon Consumer Products Corp

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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Revlon Kiss Balm SPF 20

Active Ingredients:

Avobenzone 2.0%

Octinoxate 7.5%

Oxybenzone 3.0%

Inactive Ingredients

Polybutene, Diisostearyl Malate, Isononyl Isononanoate, Bis-Diglyceryl Polyacyladipate-2, Octyldodecyl Neopentanoate, Polyethylene, Ozokerite, Diisopropyl Dimer Dilinoleate, Cera Alba ((Beeswax) Cire D Abeille), Parfum (Fragrance), Flavor, Punica Granatum Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Calcium Aluminum Borosilicate, Euphorbia Cerifera (Candelilla) Wax, Cetyl Palmitate, Benzoic Acid, Oxidized Polyethylene, BHT, Silica, Sodium Saccharin, Benzyl Benzoate, Limonene, Benzyl Alcohol, Citral, Amyl Cinnamal, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Linalool

May Contain- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 28 Lake (CI 45410), Red 33 Lake (CI 17200), Blue 1 Lake (CI 42090), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI 15985), Carmine (CI 75470

EXTERNAL USE ONLY

External Use Only

Questions?

1-800-473-8566

Product Label

Revlon Kiss Balm SPF 20

Broad Spectrum

Avobenzone- 2.0%

Octinoxate - 7.5%

Oxybenzone- 3.0%

REVLON KISS BALM SPF 20
avobenzone, benzophenone-3, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-640
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
LIMONENE, (+/-)- (UNII: 9MC3I34447)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRAL (UNII: T7EU0O9VPP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CERESIN (UNII: Q1LS2UJO3A)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
WHITE WAX (UNII: 7G1J5DA97F)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
RASPBERRY SEED OIL (UNII: 9S8867952A)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
CANDELILLA WAX (UNII: WL0328HX19)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TRIS-BHT MESITYLENE (UNII: 51DM34B894)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
BENZYL BENZOATE (UNII: N863NB338G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10967-640-19	2.6 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/19/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/19/2016

Labeler - Revlon Consumer Products Corp (788820165)

Name	Address	ID/FEI	Business Operations
Establishment
REVLON, INC.		809725570	manufacture(10967-640)