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NDC 63645-0176-03 Tea Tree Lip Balm, SPF 15 20; 45 mg/g; mg/g Details

Tea Tree Lip Balm, SPF 15 20; 45 mg/g; mg/g

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

Product Information

NDC	63645-0176
Product ID	63645-176_d5d54a65-99b5-4f3d-9e3b-93d543f7c057
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	Tea Tree Lip Balm, SPF 15
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate, Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	20; 45
Active Ingredient Units	mg/g; mg/g
Substance Name	OCTINOXATE; OXYBENZONE
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 63645-0176-03 (63645017603)

Pricing Information	N/A
NDC Package Code	63645-176-03
Billing NDC	63645017603
Package	4 g in 1 CONTAINER (63645-176-03)
Marketing Start Date	2017-10-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ce11b043-0290-4c18-afbc-df4e49656c31 Details

Active ingredient

Octinoxate (2.0%), Oxybenzone (4.5%)

Purpose

Sunscreen

Keep Out of Reach of Children

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

Uses

Prevents Sunburns

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 prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Synthetic Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Package/Label Principal Display Panel

Drug Facts Panel - Formula L-BX TTM NPIG 15

INGREDIENTS AND APPEARANCE

TEA TREE LIP BALM, SPF 15

octinoxate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-176
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	45 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)	304 mg in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	305 mg in 1 g
ACETYLATED LANOLIN (UNII: 2X654GD19H)	97 mg in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-176-03	4 g in 1 CONTAINER; Type 0: Not a Combination Product	10/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/09/2017

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-176) , LABEL(63645-176)

Revised: 11/2022

Document Id: d5d54a65-99b5-4f3d-9e3b-93d543f7c057

Set id: ce11b043-0290-4c18-afbc-df4e49656c31

Version: 2

Effective Time: 20221103