MATTIFY AND PROTECT DAILY PRIMING SPF 35- octocrylene, zinc oxide spray

Mattify and Protect Daily Priming SPF 35 by

Drug Labeling and Warnings

Mattify and Protect Daily Priming SPF 35 by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty, LLC, Bell International Laboratories, Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients Purpose

Octocrylene 7.6% Sunscreen

Zinc Oxide 6.0% Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

INDICATIONS & USAGE

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

Warnings

For external use only. Do not use on damaged or broken skin. Stop use & 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Shake well before use. Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen if swimming or sweating. Reapply after swimming or sweating. Reapply at least every 2 hours. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses. Children under 6 months: ask a doctor.

Inactive ingredients:

Aqua, Coconut Alkanes, Calcium Sodium Borosilicate, Butyloctyl Salicylate, Propanediol, Cetearyl Alcohol, Parfum (Natural), Niacinamide, Tetrahexyldecyl Ascorbate (Vitamin C), Jojoba Esters, Laminaria Digitata (Algae) Extract, Ascophyllum Nodosum Extract, Tocopherol (Vitamin E), Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl Alcohol, Citric Acid, Coco-Caprylate/ Caprate, Coco-Glucoside, Ethyl Ferulate, Glycerin, Montmorillonite, Sclerotium Gum, Sodium Gluconate, Sodium Stearoyl Glutamate, Sucrose Distearate, Sucrose Stearate, Xanthan Gum.

STORAGE AND HANDLING

Protect this product from excessive heat & direct sun.

Questions or comments?

Call toll free 1-888-322-2466
Pacifica Beauty LLC Portland, Oregon

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MATTIFY AND PROTECT DAILY PRIMING SPF 35 
octocrylene, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
MONTMORILLONITE (UNII: A585MN1H2L)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PROPANEDIOL (UNII: 5965N8W85T)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)
SUCROSE STEARATE (UNII: 274KW0O50M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
ETHYL FERULATE (UNII: 5B8915UELW)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
XANTHAN GUM (UNII: TTV12P4NEE)
COCONUT ALKANES (UNII: 1E5KJY107T)
NIACINAMIDE (UNII: 25X51I8RD4)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-213-00	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/31/2023

Labeler - Pacifica Beauty, LLC (868275517)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Incorporated		967781555	manufacture(61197-213)