GOPURE SUNSCREEN- zinc oxide lotion

goPure Sunscreen by

Drug Labeling and Warnings

goPure Sunscreen by is a Otc medication manufactured, distributed, or labeled by Natural Lifestyle Brands, LLC dba GoPure beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc oxide 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

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

apply generously and evenly 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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
children under 6 months of age: Ask a doctor
apply to face and neck as the last step in your skincare routine

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, C13-15 Alkane, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, C9-12 Alkane, Isostearic Acid, Isoamyl Laurate, Lecithin, Polyglyceryl-3 Polyricinoleate, Quaternium-90 Bentonite, Coco-Caprylate/Caprate, Caprylhydroxamic Acid, Cocos Nucifera (Coconut) Fruit Extract, Vanilla Planifolia Fruit Extract, Sodium Chloride, Ethyl Vanillin, 1,2-Hexanediol, Galactoarabinan, Triethyl Citrate, Tocophery Acetate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions or comments?

+1-800-925-4232

You may also report serious side effects to this phone number. Monday - Friday 9:00 AM - 4:00 PM PST

SPL UNCLASSIFIED SECTION

SAFE & CLEAN

Glow Pure Tinted Mineral SPF

Broad Spectrum SPF 40

CRUELTY-FREE

GLUTEN-FREE

DERMATOLOGIST RECOMMENDED

VEGAN

It's glow time

@gopurebeauty

We created goPure because we believe that everyone deserves to feel confident in their skin -Erin Keyan (goPure co-founder)

LET'S GLOW!

Manufactured for
goPure Beauty
3835 E.
Thousand Oaks
Suite R384
Westlake Village,
CA 91362

GOOD FACE PROJECT APPROVED

ANIMAL TEST-FREE
PeTA

www.gopurebeauty.com

FSC® C158805

FPO

Packaging

INGREDIENTS AND APPEARANCE

GOPURE SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83448-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C13-15 ALKANE (UNII: 114P5I43UJ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
C9-12 ALKANE (UNII: 7J5R5W72QM)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
COCONUT (UNII: 3RT3536DHY)
VANILLA BEAN (UNII: Q74T35078H)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYL VANILLIN (UNII: YC9ST449YJ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GALACTOARABINAN (UNII: SL4SX1O487)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83448-025-50	1 in 1 CARTON	08/28/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 83448-025-15	1 in 1 CARTON	02/16/2024
2		15 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 Drug	M020	08/28/2023

Labeler - Natural Lifestyle Brands, LLC dba GoPure beauty (020365598)