CHAPSTICK ULTRA SPF 30- octinoxate, octisalate, octocrylene, oxybenzone, petrolatum stick 
Wyeth Consumer Healthcare LLC

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.

----------

ChapStick Ultra SPF 30
(octinoxate, octisalate, octocrylene, oxybenzone, white petrolatum)

DRUG FACTS

ACTIVE INGREDIENTS

Octinoxate 7.5%

Octisalate 5%

Octocrylene 7%

Oxybenzone 5%

White petrolatum 30%

PURPOSES

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Skin protectant

USES

  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent sunburn
  • helps prevent and protect from the drying effects of wind and cold weather

WARNINGS

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

OTHER INFORMATION

  • store at 20-25°C (68-77°F)
  • protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

aloe barbadensis leaf extract, alumina, arachidyl propionate, carnauba wax, cetyl alcohol, colloidal silicon dioxide, ethylhexyl palmitate, isopropyl lanolate, isopropyl myristate, lanolin, methylparaben, mineral oil, natural and artificial flavor, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, polyhydroxystearic acid, propylparaben, saccharin, silica, titanium dioxide, triacetin, vitamin E, white wax

QUESTIONS OR COMMENTS?

call weekdays from 9 AM to 5 PM at 1-877-227-3421

For most recent product information, visit www.chapstick.com

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

BRAND LIP CARE
ChapStick®
SKIN PROTECTANT | SUNSCREEN

SPF 30

ACTIVE
ULTRA 30
SPF 30

NET WT 0.15 OZ (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
CHAPSTICK ULTRA SPF 30 
octinoxate, octisalate, octocrylene, oxybenzone, petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1940
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SACCHARIN (UNII: FST467XS7D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WHITE WAX (UNII: 7G1J5DA97F)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorWHITE (light ivory) Score    
ShapeBULLET (cylindrical) Size10mm
FlavorLEMON, LIMEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-1940-241 in 1 BLISTER PACK01/30/200405/31/2018
14 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:0573-1940-504 g in 1 CYLINDER; Type 0: Not a Combination Product01/30/200405/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/30/200405/31/2018
Labeler - Wyeth Consumer Healthcare LLC (828831730)

Revised: 3/2019
 
Wyeth Consumer Healthcare LLC