PLUMSCREEN SPF 31- zinc oxide cream

PLUMSCREEN by

Drug Labeling and Warnings

PLUMSCREEN by is a Otc medication manufactured, distributed, or labeled by LP FOUNDERS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ZINC OXIDE (NON-NANO) 4.7%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), THIS PRODUCT REDUCES 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 WITH WATER TO REMOVE
• STOP USE AND ASK A DOCTOR IF RASH OCCURS

KEEP OUT OF REACH OF CHILDREN

• KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE EXPOSURE TO ALL SKIN EXPOSED TO THE SUN. REAPPLY AT LEAST EVERY 2 HOURS.
• USE A WATERPROOF SUNSCREEN IF SWIMMING OR SWEATING
• CONSULT YOUR DOCTOR BEFORE APPLYING ON CHILDREN UNDER 6 MONTHS OF AGE.

OTHER INFORMATION

• TO BEST MAINTAIN FORMULA, STORE AWAY FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

WATER (AQUA), COCO-CAPRYLATE/CAPRATE, PRUNUS DOMESTICA SEED OIL, PRUNUS DOMESTICA EXTRACT, HYDROLYZED PRUNUS DOMESTICA FRUIT EXTRACT, GLYCERIN, CETEARYL ALCOHOL, CETEARYL OLIVATE, SORBITAN OLIVATE, PROPANEDIOL, ZONARIA TOURNEFORTII EXTRACT, SODIUM STEAROYL GLUTAMATE, SILICA, XANTHAN GUM, TETRASODIUM GLUTAMATE DIACETATE, POLYHYDROXYSTEARIC ACID, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCERYL ETHER

QUESTIONS?

VISIT WWW.LEPRUNIER.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PLUMSCREEN  SPF 31
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80476-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PLUM JUICE (UNII: KLB93D0YFI)
WATER (UNII: 059QF0KO0R)
PLUM SEED OIL (UNII: 67EIU8N086)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80476-101-10	1 in 1 BOX	06/21/2022
1		10 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 80476-101-60	1 in 1 BOX	06/21/2022
2		60 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 80476-101-02	2 mL in 1 PACKET; Type 0: Not a Combination Product	01/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/21/2022

Labeler - Le Prunier Farms, Inc. (118935302)