Label: REVLON KISS BALM SPF 20- avobenzone, benzophenone-3, octinoxate stick
- NDC Code(s): 10967-640-19
- Packager: Revlon Consumer Products Corp
- 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 November 11, 2019
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- Active Ingredients:
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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
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INGREDIENTS AND APPEARANCE
REVLON KISS BALM SPF 20
avobenzone, benzophenone-3, octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-640 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-640-19 2.6 mL in 1 CONTAINER; Type 0: Not a Combination Product 09/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/19/2016 Labeler - Revlon Consumer Products Corp (788820165) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(10967-640)
Revlon Kiss Balm SPF 20