FDA.reportPublic FDA data

Annmarie SPF 20 Sunscreen

Manufacturer
Annmarie Gianni Skin Care LLC | Derma Care Research Labs, LLC
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:46

Label at a glance#

ProductAnnmarie SPF 20 Sunscreen
Active ingredientZINC OXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying 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 risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other su...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure. Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil*, Sorbitan Olivate, Cannabis Sativa Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Cucurbita Pepo (Pumpkin) Seed Oil*, Beeswax*, Lavandula Angustifolia (Lavender) Oil, Persea Gratissima (Avocado) Oil*, Mauritia Flexuosa Fruit Oil, Tocopherol. *Organic

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82052-157-01Annmarie SPF 20 Sunscreen50 mL in 1 BOTTLE, PUMPLOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82052-157ANNMARIE SPF 20 SUNSCREEN (ZINC OXIDE 15%) LOTION [ANNMARIE GIANNI SKIN CARE LLC]3Current NDC, Legacy NDC, 1 package rows20241217_cc722ce1-0ded-19d5-e053-2995a90a7d03.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82052-15782052-157-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
SORBITAN OLIVATEMDL271E3GRIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
OLIVE OIL6UYK2W1W1EIACT
PUMPKIN SEED OIL6E5QR5USSPIACT
YELLOW WAX2ZA36H0S2VIACT
LAVENDER OILZBP1YXW0H8IACT
AVOCADO OIL6VNO72PFC1IACT
ZINC OXIDESOI2LOH54ZACTIB
MAURITIA FLEXUOSA FRUIT OIL48H19MS04LIACT
TOCOPHEROLR0ZB2556P8IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Annmarie SPF 20 SunscreenZINC OXIDE 15%Annmarie Gianni Skin Care LLCcc722ce1-0ded-19d5-e053-2995a90a7d032024-12-15WarningsExact identifier
ndc (package): 82052-157-01
ndc (product): 82052-157
ndc11 (package): 82052015701
spl id: 29577ef9-f216-1dc6-e063-6394a90a44ab
spl set id: cc722ce1-0ded-19d5-e053-2995a90a7d03

Reported adverse events (FAERS/openFDA)#

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