ANNMARIE SPF 20 SUNSCREEN- zinc oxide 15% lotion 
Annmarie Gianni Skin Care LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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:

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:

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

Carton

ANNMARIE SPF 20 SUNSCREEN 
zinc oxide 15% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82052-157
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82052-157-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/20/2021
Labeler - Annmarie Gianni Skin Care LLC (050591758)
Registrant - Derma Care Research Labs, LLC (116817470)

Revised: 1/2023
Document Id: f1d7d0a1-b98f-40c5-e053-2a95a90a3147
Set id: cc722ce1-0ded-19d5-e053-2995a90a7d03
Version: 2
Effective Time: 20230109
 
Annmarie Gianni Skin Care LLC