NDC | 61369-105-11 |
Set ID | da53cae0-ffe6-4596-94be-78b4d4e4aeab |
Category | HUMAN OTC DRUG LABEL |
Packager | CoLabs Intl. Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
- DIRECTIONS
-
OTHER SAFETY INFORMATION
SUN PROTECTION MEASURES: 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 10 A.M. - 2 P.M.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
- CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
OTHER INFORMATION
- PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT EXPOSURE TO SUNLIGHT.
-
INACTIVE INGREDIENTS
CERA ALBA (BEESWAX), WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BIS-PEG-METHYL ETHER DIMETHYL SILANE, POLYETHYLENE, THEOBROMA CACAO (COCOA) SEED BUTTER, BUTYROSPERMUM PARKII (SHEA) BUTTER, SORBITAN STEARATE, SORBITAN OLEATE, POLYSORBATE 20, TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER, OCTYLDECANOL, PHENOXYETHANOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, TRIMETHOXYBENZYLIDENE PENTANEDIONE, POLYAMIDE-3, ALGIN, CHITOSAN
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KLENSKIN BROAD SPECTRUM SUNSCREEN SPF-30
avobenzone, homosalate, octisalate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61369-105 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) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) COCOA BUTTER (UNII: 512OYT1CRR) SHEA BUTTER (UNII: K49155WL9Y) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYSORBATE 20 (UNII: 7T1F30V5YH) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) OCTYLDODECANOL (UNII: 461N1O614Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .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) TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25) POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X) SODIUM ALGINATE (UNII: C269C4G2ZQ) POLIGLUSAM (UNII: 82LKS4QV2Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61369-105-11 14.2 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2018 Labeler - CoLabs Intl. Corp (829850879)