Search by Drug Name or NDC

NDC 58892-0339-45 TiZO Tinted Lip Protection SPF 45 40; 55 mg/g; mg/g Details

TiZO Tinted Lip Protection SPF 45 40; 55 mg/g; mg/g

TiZO Tinted Lip Protection SPF 45 is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Fallien Cosmeceuticals, LTD. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	58892-0339
Product ID	58892-339_2c90fbfd-3449-4a54-91b5-d51c63f3e630
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	TiZO Tinted Lip Protection SPF 45
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	40; 55
Active Ingredient Units	mg/g; mg/g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Fallien Cosmeceuticals, LTD
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 58892-0339-45 (58892033945)

Pricing Information	N/A
NDC Package Code	58892-339-45
Billing NDC	58892033945
Package	1 TUBE in 1 CARTON (58892-339-45) / 4.5 g in 1 TUBE
Marketing Start Date	2022-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2 Details

Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Purpose

Sunscreen

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.

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 mintues before sun exposure.

Reapply:
After 80 mintues of swimming or sweating
Immediately after towel drying
At least every 2 hours
Children under 6 months: 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:

-

Limit time in the sun, especially from 10:00 am-2:00 pm

-

Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, PolygIyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicapryte, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics

Principal Display Panel – 4.5 g Carton Label

TIZO®

TINTED LIP PROTECTION

MINERAL SUNSCREEN

SPF

45

SPF 45 Broad Spectrum

Water Resistant (80 minutes)

Net Wt. .14 oz./4.5 g.

INGREDIENTS AND APPEARANCE

TIZO TINTED LIP PROTECTION SPF 45

titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58892-339
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	55 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
KIWI FRUIT OIL (UNII: 66086CWP3Q)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CERESIN (UNII: Q1LS2UJO3A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINGER OIL (UNII: SAS9Z1SVUK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58892-339-45	1 in 1 CARTON	10/01/2022
1		4.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/01/2022

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(58892-339)

Name	Address	ID/FEI	Business Operations
Establishment
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-339) , PACK(58892-339)

Revised: 10/2022

Document Id: 2c90fbfd-3449-4a54-91b5-d51c63f3e630

Set id: 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2

Version: 2

Effective Time: 20221001