BEAUTYCOUNTER COUNTERSUN DAILY SHEER DEFENSE FOR FACE SPF 25- zinc oxide lotion

BEAUTYCOUNTER COUNTERSUN DAILY SHEER DEFENSE FOR FACE by

Drug Labeling and Warnings

BEAUTYCOUNTER COUNTERSUN DAILY SHEER DEFENSE FOR FACE by is a Otc medication manufactured, distributed, or labeled by Gordon Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient

Zinc Oxide 14.96%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses * Helps prevent sunburn.

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

WARNINGS

Warnings

For external use only.

-------------------------------------------------------

Do not use on damaged or broken skin.

-------------------------------------------------------
When using this product, keep out of

eyes. Rinse with water to remove.

-------------------------------------------------------
Stop use and ask a doctor if rash occurs.

------------------------------------------------------

Keep out of reach of children.

If swallowed, get medical help or contact

a Poison Control Center right away.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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

DIRECTIONS

Directions *Apply liberally and

evenly 15 minutes before sun exposure.

* Reapply at least every 2 hours.

* Use a water-resistant sunscreen if

swimming or sweating.

* 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 usa 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

Other information * Protect the

product in this container from excessive

heat and direct sun.

INACTIVE INGREDIENTS

Inactive ingredients

Water, Coco-Caprylate, Caprylic/Capric Triglyceride, Squalane, Glycerin, Pentylene Glycol, Cetearyl Alcohol, Coconut Alkanes, Arachidyl Alcohol, Coco-Glucoside, Phenoxyethanol, Behenyl Alcohol, Tocopherol, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Arachidyl Glucoside, Phytic Acid, Isostearic Acid, Lecithin, Cichorium Intybus (Chicory) Root Extract, Helianthus Annuus (Sunflower) Seed Oil*, Coco-Caprylate/Caprate, Ethylhexylglycerin, Sodium Hyaluronate.

*Organic

QUESTIONS

Questions? (888) 701-9899

Serious side effects associated with use

of this product may be reported to this number.

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

BEAUTYCOUNTER COUNTERSUN DAILY SHEER DEFENSE FOR FACE  SPF 25
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21839-615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	149.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SQUALANE (UNII: GW89575KF9)
COCO-CAPRYLATE (UNII: 4828G836N6)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT ALKANES (UNII: 1E5KJY107T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
FYTIC ACID (UNII: 7IGF0S7R8I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHICORY ROOT (UNII: 090CTY533N)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21839-615-01	1 in 1 BOX	06/08/2020
1	NDC: 21839-615-02	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/08/2020

Labeler - Gordon Laboratories, Inc. (008328619)

Registrant - Gordon Laboratories, Inc. (008328619)

Establishment
Name	Address	ID/FEI	Business Operations
Gordon Laboratories, Inc.		008328619	manufacture(21839-615)