Label: ANNMARIE SPF 20 SUNSCREEN- zinc oxide 15% lotion
- NDC Code(s): 82052-157-01
- Packager: Annmarie Gianni Skin Care LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated January 9, 2023
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- Active Ingredients
- Keep Out of Reach of Children.
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
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)