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NDC 63645-0181-03 OraLabs SPF 15 Lip Balm 30; 75; 423 mg/g; mg/g; mg/g Details

OraLabs SPF 15 Lip Balm 30; 75; 423 mg/g; mg/g; mg/g

OraLabs SPF 15 Lip Balm is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is AVOBENZONE; OCTINOXATE; PETROLATUM.

Product Information

NDC	63645-0181
Product ID	63645-181_3ac8569f-4b11-4536-8919-234f79bbd7fc
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	OraLabs SPF 15 Lip Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Octinoxate, Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	30; 75; 423
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; OCTINOXATE; PETROLATUM
Labeler Name	OraLabs
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63645-0181-03 (63645018103)

Pricing Information	N/A
NDC Package Code	63645-181-03
Billing NDC	63645018103
Package	4.25 g in 1 CONTAINER (63645-181-03)
Marketing Start Date	2022-06-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3ac8569f-4b11-4536-8919-234f79bbd7fc Details

Active ingredient

Avobenzone (3.0%), Octinoxate (7.5%)

Petrolatum (42.3%)

Purpose

Sunscreen, Sunscreen, Skin Protectant

Keep Out of Reach of Children

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

Uses

Helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early 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. When using this product. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash occurs

Directions

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. SunProtectionMeasures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Isopropyl Lanolate, Lanolin, Parraffin, Saccharin, Tocopheryl Acetate, Tocerpheryl Linoleate/Oleate.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ORALABS SPF 15 LIP BALM

avobenzone, octinoxate, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-181
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	423 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PARAFFIN (UNII: I9O0E3H2ZE)	230 mg in 1 g
ISOCETYL STEARATE (UNII: 3RJ7186O9W)	140 mg in 1 g
LANOLIN (UNII: 7EV65EAW6H)	10 mg in 1 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	10 mg in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-181-03	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	06/20/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/20/2022

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-181) , LABEL(63645-181)

Revised: 9/2022

Document Id: 3ac8569f-4b11-4536-8919-234f79bbd7fc

Set id: 3ac8569f-4b11-4536-8919-234f79bbd7fc

Version: 1

Effective Time: 20220921