CHAPSTICK MOISTURIZER COOL MINT- avobenzone, octinoxate, and white petrolatum stick

Chapstick Moisturizer Cool Mint by

Drug Labeling and Warnings

Chapstick Moisturizer Cool Mint by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Avobenzone 3%
Octinoxate 7.5%	Sunscreens
White petrolatum 41.4%	Skin protectant

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
• helps prevent and temporarily protects chafed, chapped or cracked lips
• helps prevent and protect from the drying effects of wind and cold weather

Warnings

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
• 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 value of 15 or higher and other sun protection measures including:
  • limited time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

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, artificial flavor, carnauba wax, cetyl alcohol, isocetyl stearate, isopropyl lanolate, lanolin, medium-chain triglycerides, mineral oil, paraffin, saccharin, 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

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

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 Label

ChapStick®

SKIN PROTECTANT | SUNSCREEN
BROAD SPECTRUM SPF 15

MOISTURIZER | Cool Mint

8
HOUR
MOISTURE

SPF 15

INGREDIENTS AND APPEARANCE

CHAPSTICK MOISTURIZER COOL MINT 
avobenzone, octinoxate, and white petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0768
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	414 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	42mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0768-12	1 in 1 BLISTER PACK	06/28/2018
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 0573-0768-39	3 in 1 BLISTER PACK	06/28/2018
2		4 g in 1 CYLINDER; Type 0: Not a Combination Product
3	NDC: 0573-0768-40	3 in 1 BLISTER PACK	06/28/2018
3		4 g in 1 CYLINDER; Type 0: Not a Combination Product
4	NDC: 0573-0768-51	4 g in 1 CYLINDER; Type 0: Not a Combination Product	06/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/28/2018

Labeler - Wyeth Consumer Healthcare LLC (828831730)