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NDC 00573-1958-01 Chapstick Moisturizer Original 30; 40; 45; 26; 384 mg/g; mg/g; mg/g; mg/g; mg/g Details

Chapstick Moisturizer Original 30; 40; 45; 26; 384 mg/g; mg/g; mg/g; mg/g; mg/g

Chapstick Moisturizer Original is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; PETROLATUM.

Product Information

NDC	00573-1958
Product ID	0573-1958_de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Chapstick Moisturizer Original
Proprietary Name Suffix	n/a
Non-Proprietary Name	avobenzone, homosalate, octisalate, octocrylene, white petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	30; 40; 45; 26; 384
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; PETROLATUM
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00573-1958-01 (00573195801)

Pricing Information	N/A
NDC Package Code	0573-1958-01
Billing NDC	00573195801
Package	3 CYLINDER in 1 BLISTER PACK (0573-1958-01) / 4 g in 1 CYLINDER
Marketing Start Date	2022-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5 Details

Active ingredients

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 38.4%

Purposes

Sunscreens

Skin protectant

Uses

•: helps prevent sunburn
•: helps prevent and temporarily protects chafed, chapped or cracked lips
•: 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, alpha-isomethyl ionone, anise alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, BHT, cetyl alcohol, copernicia cerifera (carnauba) wax, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl

acetate, tocopheryl linoleate/oleate, white beeswax

Questions or comments?

call weekdays from 9 AM to 6 PM EST at 1-800-245-1040

Additional information

Paraben Free

Dist by: GSK CH, Warren, NJ 07059

For most recent product information,

visit www.chapstick.com

Trademarks owned or licensed by GSK.

PRINCIPAL DISPLAY PANEL

NEW Formula

BRAND LIP CARE

ChapStick®

SKIN PROTECTANT | SUNSCREENS

SPF 12

MOISTURIZER Original

2 in 1 Lipcare

8 HOUR MOISTURE

SPF 12

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000073769

INGREDIENTS AND APPEARANCE

CHAPSTICK MOISTURIZER ORIGINAL

avobenzone, homosalate, octisalate, octocrylene, white petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1958
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	384 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
PARAFFIN (UNII: I9O0E3H2ZE)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0573-1958-01	3 in 1 BLISTER PACK	04/01/2022
1		4 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/01/2022

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 2/2022

Document Id: de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5

Set id: de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5

Version: 1

Effective Time: 20220218