ChapStick® Hydration Lock Day and Night

ChapStick Hydration Lock Day and Night by

Drug Labeling and Warnings

ChapStick Hydration Lock Day and Night by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHAPSTICK HYDRATION LOCK DAY AND NIGHT- white petrolatum, octinoxate, oxybenzone 
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.

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ChapStick® Hydration Lock Day and Night

ChapStick® Day

Drug Facts

Active ingredientsPurposes
Octinoxate 7.5%
Oxybenzone 3.5%		Sunscreens
White petrolatum 40.7%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, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, isopropyl myristate, lanolin, methylparaben, mineral oil, paraffin, propylparaben, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Questions or comments?

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

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

ChapStick® Night

Ingredients

helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, copernicia cerifera (carnauba) wax, tocopheryl acetate, mangifera indica (mango) seed butter, butyrospermum parkii (shea butter), octyldodecanol, flavor, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, calophyllum tacamahaca seed oil, tocopherol, hydrogenated soybean oil, rubus idaeus (raspberry) seed oil, glyceryl stearate

PRINCIPAL DISPLAY PANEL - 2.2 g Cylinder Label

ChapStick®

night

hydration lock
SKIN PROTECTANT
SUNSCREEN

day
SPF 12

PAA051527

Day (SPF 12): NET WT 0.077 OZ (2.2 g)
Night: NET WT 0.077 OZ (2.2 g)

Principal Display Panel - 2.2 g Cylinder Label

PRINCIPAL DISPLAY PANEL - 2.2 g Blister Pack Label

2 FORMULAS IN 1
NON-TINTED

ChapStick®

hydration lock

24
HOUR
CARE

BLISTER

day

SPF
12

SKIN PROTECTANT | SUNSCREEN
ultra-conditioning
daytime formula

night

replenishes overnight
with tamanu oil, natural
butters, and antioxidants

Day (SPF 12): NET WT 0.077 OZ (2.2 g)
Night: NET WT 0.077 OZ (2.2 g)

Principal Display Panel - 2.2 g Blister Pack Label
CHAPSTICK HYDRATION LOCK DAY AND NIGHT 
white petrolatum, octinoxate, oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0573-1961
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0573-1961-101 in 1 BLISTER PACK08/01/201412/31/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CYLINDER 2.2 g
Part 21 CYLINDER 2.2 g
Part 1 of 2
CHAPSTICK HYDRATION LOCK DAY 
white petrolatum, octinoxate, oxybenzone stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE35 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM407 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12.2 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER08/01/201412/31/2019
Part 2 of 2
CHAPSTICK HYDRATION LOCK NIGHT 
night stick
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRCANDELILLA WAX (UNII: WL0328HX19)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGROCTYLDODECANOL (UNII: 461N1O614Y)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRCALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRHYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
INGRRASPBERRY SEED OIL (UNII: 9S8867952A)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12.2 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC08/01/201412/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/01/201412/31/2019
Labeler - Wyeth Consumer Healthcare LLC (828831730)

Revised: 3/2019
Document Id: a406a436-fd31-4573-8bb3-eac59104300d
Set id: 01924c63-6d3f-4a35-89cb-aa9a73d7e446
Version: 3
Effective Time: 20190308