sunscreen

Manufacturer: True Botanicals, Inc.
Effective date: 2024-10-18
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:27:33

Label at a glance#

Productsunscreen

Active ingredientZINC OXIDE

Label structure8 sections

Indications and uses

Helps prevent sunburn If used as diercted with other sun protection measures, decreasis the risk of skin cancer and wearly sighs of aging caused by the sun.

Dosage and administration

• Apply liberally and evenly as the last step in your skincare routine, before makeup and 15 minutes before sun exposure. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating: immediately after towel drying at least every 2 hours.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

If used as diercted with other sun protection measures, decreasis the risk of skin cancer and wearly sighs of aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask doctor

OTC - ASK DOCTOR SECTION

Stop use and ask doctor if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally and evenly as the last
step in your skincare routine, before
makeup and 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if
swimming or sweating: immediately after
towel drying at least every 2 hours.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

camellia sinensis leaf (green tea) water, caprylic/capric
triglyceride, coco-caprylate, glycerin*, polyglyceryl-6
stearate, capryloyl glycerin/sebacic acid copolymer, water,
oryza sativa (rice) bran extract, squalane, polyhydroxystearic
acid, hippophae rhamnoides (seabuckthorn) seed oil*,
silybum marianum (milk thistle) ethyl ester, pisum sativum
(pea) peptide, terminalia chebula fruit extract, haematococcus
pluvialis (astaxanthin) powder*, simmondsia chinensis
(jojoba) seed oil*, aloe barbadensis leaf juice*, camellia
sinensis leaf (green tea) extract, citrus aurantium amara
(bitter orange) flower distillate*, isopropyl jojobate, jojoba
alcohol, jojoba esters, xanthan gum, polyglyceryl-6 behenate,
lactic acid, acacia senegal gum, dipotassium glycyrrhizate,
allantoin, phenethyl alcohol, ethylhexylglycerin, sodium
phytate, glycerin, leuconostoc/radish root ferment filtrate,
tocopherol.

Other Information

OTHER SAFETY INFORMATION

• Protect the product in this container from
excessive heat and direct sun.

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-4160870 M-F 9am-5pm EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82516-101-01	sunscreen	50 g in 1 BOTTLE	CREAM	50		7
82516-101-02	sunscreen	1 in 1 CARTON	CREAM	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82516-101	SUNSCREEN (SKIN BARRIER SUN SHIELD SPF 30) CREAM [TRUE BOTANICALS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241020_d70eea23-7715-c17b-e053-2a95a90a839f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

sunscreen
Skin Barrier Sun Shield SPF 30
ZINC OXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82516-101	82516-101-01, 82516-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sunscreen	SKIN BARRIER SUN SHIELD SPF 30	True Botanicals, Inc.	d70eea23-7715-c17b-e053-2a95a90a839f	2024-10-18	Warnings	Exact identifier ndc (package): 82516-101-02 ndc (package): 82516-101-01 ndc (product): 82516-101 ndc11 (package): 82516010102 ndc11 (package): 82516010101 spl id: 24c1c21b-f96e-484b-e063-6394a90a895f spl set id: d70eea23-7715-c17b-e053-2a95a90a839f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.