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

Prismplus Broad-Spectrum Sunscreen SPF 43 by

Drug Labeling and Warnings

Prismplus Broad-Spectrum Sunscreen SPF 43 by is a Otc medication manufactured, distributed, or labeled by Merz North America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 - 50 mL Bottle Carton

SUNSCREEN

PRISM+

Defense Cream
Broad-Spectrum Sunscreen SPF 43
Water Resistant (80 minutes)

NEO

Powered by
Lightshield Technology

NEOCUTIS®

1.69 FL. OZ. (50 ML)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Merz North America, Inc (028147846)