Label: KLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS)- avobenzone, homosalate, octisalate lipstick
- NDC Code(s): 61369-301-23
- Packager: CoLabs Intl. Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
- DIRECTIONS
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OTHER INFORMATION
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m.-2p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor.
• Protect this product from excessive heat & direct sunlight.
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INACTIVE INGREDIENTS
Cera Alba (Beeswax), Caprylic/Capric Triglyceride, Water, Polyethylene, Theobroma Cacao (Cocoa) Seed Butter, Bis-PEG-18 Methyl Ether Dimethyl Silane, Flavor, Butyrospermum parkii (Shea) Butter, Sorbitan Stearate, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Octyldecanol, Trimethoxybenzylidene Pentanedione, Stevia Rebaudiana Leaf Extact, Sodium Saccharin, Tocopheryl Acetate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum (Pomegranate) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chitosan, Algin, Phenoxyethanol, Ethylhexylglycerin
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INGREDIENTS AND APPEARANCE
KLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS)
avobenzone, homosalate, octisalate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61369-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.2 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.3 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) COCOA BUTTER (UNII: 512OYT1CRR) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) SHEA BUTTER (UNII: K49155WL9Y) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) OCTYLDODECANOL (UNII: 461N1O614Y) TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SACCHARIN SODIUM (UNII: SB8ZUX40TY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) GRAPE SEED OIL (UNII: 930MLC8XGG) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) TEA TREE OIL (UNII: VIF565UC2G) CHITOSAN HIGH MOLECULAR WEIGHT (400-800 MPA.S) (UNII: 7SRJ3W89J8) SODIUM ALGINATE (UNII: C269C4G2ZQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61369-301-23 4.25 g in 1 TUBE; Type 0: Not a Combination Product 08/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/15/2018 Labeler - CoLabs Intl. Corp (829850879)
