Search by Drug Name or NDC

NDC 52667-0006-96 100% Pure Yerba Mate MIst 120 mg/mL Details

100% Pure Yerba Mate MIst 120 mg/mL

100% Pure Yerba Mate MIst is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Purity Cosmetics. The primary component is ZINC OXIDE.

Product Information

NDC	52667-0006
Product ID	52667-006_4e77a097-eb23-4d14-e054-00144ff88e88
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	100% Pure Yerba Mate MIst
Proprietary Name Suffix	SPF 30
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	120
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	Purity Cosmetics
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52667-0006-96 (52667000696)

Pricing Information	N/A
NDC Package Code	52667-006-96
Billing NDC	52667000696
Package	96 mL in 1 BOTTLE, SPRAY (52667-006-96)
Marketing Start Date	2017-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4e7798fb-1b01-62e3-e054-00144ff8d46c Details

Active Ingredients

Zinc Oxide 12%

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 aging caused by the sun.

Warnings

Contents under pressure. Do not puncture or incinerate.
For external use only
Do not spray directly on face.
Do not use on damaged or broken skin.
S top use and ask a doctor if rash occurs.
When using this product keep out of eyes. Rinse with water to remove.

SPL UNCLASSIFIED SECTION

When using this product, keep out of eye. Rinse with water to remove.

SPL UNCLASSIFIED SECTION

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

Directions

Do not spray directly onto face. Spray into hands and rub onto your face.
To ensure adequate sun protection, avoid spreading too thinly when applying.
Shake well before use.
Apply liberally 15 minutes before sun exposure.
Reapply: after 80 minutes of swimming or sweating / immediately after towel drying / at least every 2 hours
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 of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.
Children under 6 months: Consult a physician.

Other Ingredients

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Jojoba Ester, Methyl Dihydroabietate, Water

Other information

Protect this product from excessive heat and direct sunlight.

Questions or comments?

call 1.844.787.3100 or visit www.100PercentPure.com

100% Pure Yerba Mate Mist SPF 30

INGREDIENTS AND APPEARANCE

100% PURE YERBA MATE MIST SPF 30

zinc oxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52667-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
COCO GLUCOSIDE (UNII: ICS790225B)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52667-006-96	96 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/01/2017

Labeler - Purity Cosmetics (055795259)

Name	Address	ID/FEI	Business Operations
Establishment
Bell International Laboratories		967781555	manufacture(52667-006)

Revised: 5/2017

Document Id: 4e77a097-eb23-4d14-e054-00144ff88e88

Set id: 4e7798fb-1b01-62e3-e054-00144ff8d46c

Version: 1

Effective Time: 20170501

Search by Drug Name or NDC

NDC 52667-0006-96 100% Pure Yerba Mate MIst 120 mg/mL Details

100% Pure Yerba Mate MIst 120 mg/mL

Product Information

Package

Package Images

NDC 52667-0006-96 (52667000696)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4e7798fb-1b01-62e3-e054-00144ff8d46c Details

Active Ingredients

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other Ingredients

Other information

Questions or comments?

100% Pure Yerba Mate Mist SPF 30

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?