NDC Code(s) : 0573-0768-12, 0573-0768-39, 0573-0768-40, 0573-0768-51
Packager : Haleon US Holdings LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Chapstick Moisturizer Cool Mintavobenzone, octinoxate, and white petrolatum STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0768
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U)
(PETROLATUM - UNII:4T6H12BN9U) 		PETROLATUM414 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CETYL ALCOHOL(UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL LINOLEATE, D-(UNII: G0N132Q0ED)
ISOCETYL STEARATE(UNII: 3RJ7186O9W)
LANOLIN(UNII: 7EV65EAW6H)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
MINERAL OIL(UNII: T5L8T28FGP)
PARAFFIN(UNII: I9O0E3H2ZE)
SACCHARIN(UNII: FST467XS7D)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WHITE WAX(UNII: 7G1J5DA97F)
Product Characteristics
Color YELLOW Score
Shape BULLET Size 42 mm
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0573-0768-121 in 1 BLISTER PACK 28/06/2018
14 g in 1 CYLINDER Type 0: Not a Combination Product
2NDC:0573-0768-393 in 1 BLISTER PACK 28/06/2018
24 g in 1 CYLINDER Type 0: Not a Combination Product
3NDC:0573-0768-403 in 1 BLISTER PACK 28/06/2018
34 g in 1 CYLINDER Type 0: Not a Combination Product
4NDC:0573-0768-514 g in 1 CYLINDER Type 0: Not a Combination Product28/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 06/28/2018

LABELER - Haleon US Holdings LLC(079944263)

PRINCIPAL DISPLAY PANEL

NEW
Improved
Formula

BRAND LIP CARE
ChapStick®

SKIN PROTECTANT | SUNSCREEN
BROAD SPECTRUM SPF 15

MOISTURIZER
2 in 1 Lipcare

8 HOUR MOISTURE
SPF 15

Cool Mint

NET WT
0.15 OZ (4 g)

Principal Display Panel - 4 g Cylinder Blister Pack