ANNMARIE SPF 20 SUNSCREEN- zinc oxide 15% lotion

Annmarie SPF 20 Sunscreen by

Drug Labeling and Warnings

Annmarie SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Annmarie Gianni Skin Care LLC, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 15%

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 eyes 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 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

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

INGREDIENTS AND APPEARANCE

ANNMARIE SPF 20 SUNSCREEN 
zinc oxide 15% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82052-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
OLIVE OIL (UNII: 6UYK2W1W1E)
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)
YELLOW WAX (UNII: 2ZA36H0S2V)
LAVENDER OIL (UNII: ZBP1YXW0H8)
AVOCADO OIL (UNII: 6VNO72PFC1)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82052-157-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/20/2021

Labeler - Annmarie Gianni Skin Care LLC (050591758)

Registrant - Derma Care Research Labs, LLC (116817470)