PRISMPLUS BROAD-SPECTRUM SUNSCREEN SPF 43- octinoxate, octisalate, and zinc oxide lotion
Merz North America, Inc

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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Prism+ Broad-Spectrum Sunscreen SPF 43

Drug Facts

Active Ingredients

Octinoxate 7.5%
Octisalate 5.0%
Zinc Oxide 9.4%

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 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 generously 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am - 2pm
- wear long-sleeved shirts, pants,hats, and sunglasses
children under 6 months of age: ask a doctor

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Octyldodecyl Neopentanoate, Butylene Glycol, Diatomaceous Earth, Diisopropyl Sebacate, Tocopheryl Acetate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetyl Dimethicone, Isopropyl Palmitate, Carnosine, Melanin, Tocopherol, Hydrogenated Castor Oil, Beeswax, Ethylhexylglycerine, Sodium Chloride, Disodium EDTA, Triethoxycaprylylsilane, Neopentanoic Acid, Polyhydroxystearic Acid, Pentylene Glycol, Octyldodecanol, BHT, Phenoxyethanol

Other Information

protect this product from excessive heat and direct sun

Questions?

1.844.469.6379

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton

prism +

DEFENSE CREAM
BROAD-SPECTRUM SUNSCREEN SPF 43
WATER RESISTANT (80 MINUTES)

NEOCUTIS®

Principal Display Panel - 150 mL Bottle Carton

PRISMPLUS BROAD-SPECTRUM SUNSCREEN SPF 43
octinoxate, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46783-223
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	94 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Butylene Glycol (UNII: 3XUS85K0RA)
Diatomaceous Earth (UNII: 2RF6EJ0M85)
Diisopropyl Sebacate (UNII: J8T3X564IH)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Cetyl Dimethicone 25 (UNII: U4AS1BW4ZB)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Carnosine (UNII: 8HO6PVN24W)
Melanin Synthetic (Tyrosine, Peroxide) (UNII: O0CV1RMR44)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
Yellow Wax (UNII: 2ZA36H0S2V)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Chloride (UNII: 451W47IQ8X)
Edetate Disodium (UNII: 7FLD91C86K)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Pivalic Acid (UNII: 813RE8BX41)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Pentylene Glycol (UNII: 50C1307PZG)
Octyldodecanol (UNII: 461N1O614Y)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Phenoxyethanol (UNII: HIE492ZZ3T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46783-223-15	1 in 1 CARTON	06/01/2018	10/24/2021
1		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:46783-223-50	1 in 1 CARTON	06/01/2018	10/24/2021
2		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:46783-223-04	4 mL in 1 TUBE; Type 0: Not a Combination Product	06/15/2019	10/24/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2018	10/24/2021

Labeler - Merz North America, Inc (028147846)

Revised: 1/2022

Document Id: ab2ddc83-0010-4b02-b7f7-451a9b18e9b9

Set id: 9980e0ac-6be6-40b5-822b-d500161f2131

Version: 5

Effective Time: 20220112

Merz North America, Inc