CHAPSTICK MOISTURIZER GREEN APPLE- avobenzone, octinoxate, and white petrolatum stick

Chapstick Moisturizer Green Apple by

Drug Labeling and Warnings

Chapstick Moisturizer Green Apple by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) 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 39.6%	Skin protectant

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf extract, artificial flavors, benzyl alcohol, blue 1 lake, carnauba wax, cetyl alcohol, isocetyl stearate, isopropyl lanolate, lanolin, lecithin (soy), medium-chain triglycerides, mineral oil, paraffin, partially hydrogenated vegetable oil, red 40 lake, saccharin, titanium dioxide, tocopheryl linoleate/oleate, vitamin E acetate, white wax, yellow 6 lake, yellow 10 lake

QUESTIONS

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

Green Apple

NET WT
0.15 OZ (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Label

ChapStick®

SKIN PROTECTANT | SUNSCREEN
BROAD SPECTRUM SPF 15

MOISTURIZER | Green Apple

8
HOUR
MOISTURE

SPF 15

INGREDIENTS AND APPEARANCE

CHAPSTICK MOISTURIZER GREEN APPLE 
avobenzone, octinoxate, and white petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0728
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	396 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
LANOLIN (UNII: 7EV65EAW6H)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
SACCHARIN (UNII: FST467XS7D)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	GREEN	Score
Shape	BULLET	Size	42mm
Flavor	APPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0728-12	1 in 1 BLISTER PACK	06/28/2018
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 0573-0728-40	3 in 1 BLISTER PACK	06/28/2018
2		4 g in 1 CYLINDER; Type 0: Not a Combination Product
3	NDC: 0573-0728-51	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)