Topco Everyday Mineral Sunscreen Continuous Spray Broad Spectrum SPF 50

Topco Everyday Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Topco Everyday Mineral Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOPCO EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide spray 
TOPCO ASSOCIATES LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Topco Everyday Mineral Sunscreen Continuous Spray Broad Spectrum SPF 50

Active ingredients

Titanium Dioxide 3.5%

Zinc Oxide 7.25%

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

FLAMMABLE:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

​Do not use

• ​​on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

keep away from to avoid breathing it.

do not puncture or incinerate. Contents under pressure.

do not store at temperatures above 120° F.

Stop use and ask doctor if​

​

• rash occurs.

Keep out of reach of children. ​

​If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

spray liberally and spread evenly by hand 15 minutes before sun exposure
hold can 4-6 inches away from skin top apply
do not spray into face. Spray into hand and apply to face.
use in a well ventilated areas

reapply:
after 80 minutes 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 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

protect the product in the container from excessive heat and direct sun
may stain or damage some fabrics

Inactive ingredients

Aloe Barbadensis Leaf Juice, Shea Butter Ethyl Esters, Neopentyl Glycol Diheptanoate,Butyloctyl Salicylate, Simmondsia Chinensis (Jojoba) Seed Oil, Olive Oil, Polyglyceryl-6 Esters, Polyglyceryl-6 Pentaoleate, Phenoxyethanol, Stearyl/Octyldodecyl Citrate Crosspolymer, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, VP/Hexadecene Copolymer, Glycerin, Aluminum Hydroxide, Stearic Acid,Magnesium Sulfate, Glyceryl Stearate,Xanthan Gum, Ethylhexylglycerin,Tocopherol

Label

Topco Everyday Mineral Sunscreen Continuous Spray Broad Spectrum SPF 50

6.3 oz (178 g)

TOPCO EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	72.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-073-50	179 g in 1 CAN; Type 0: Not a Combination Product	01/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/22/2020	02/15/2023

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 2/2023

Document Id: f4da2d4b-966a-09a5-e053-2995a90ac997

34390-5

Set id: c5283cc4-c3da-55ba-e053-2995a90a7d67

Version: 2

Effective Time: 20230216