TRIPLE PREP SPF 40- avobenzone, octisalate, octocrylene, homosalate lotion

Triple Prep SPF 40 by

Drug Labeling and Warnings

Triple Prep SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Avobenzone 3%, Homosalate 7%, Octisalate 5%, Octocrylene 6%

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

DOSAGE & ADMINISTRATION

Apply generously and evenly 15 minutes before sun exposure

Reapply 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Water, Isododecane, Butyloctyl Salicylate, Calcium Aluminum Borosilicate, Glycerin, Polymethylsilsesquioxane, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ectoin, Acrylates Crosspolymer, Gluconolactone, Arginine, Butylene Glycol, Sodium Benzoate, Polyacrylate Crosspolymer-6, Bisabolol, Tocopherol, Citric Acid, Niacinamide, Sodium Dilauramidoglutamide Lysine, Sodium Hyaluronate, Calcium Gluconate, Sodium Polyglutamate, Hydrolyzed Rhodophyceae Extract

PRINCIPAL DISPLAY PANEL

TRIPLE PREP

Weightless Multitasking Moisturizer

SPF 40

Broad Spectrum Sunscreen SPF 40 PA +++

1.7 fl. oz. / 50 mL

INGREDIENTS AND APPEARANCE

TRIPLE PREP SPF 40 
avobenzone, octisalate, octocrylene, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ARGININE (UNII: 94ZLA3W45F)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TOCOPHEROL (UNII: R0ZB2556P8)
ECTOINE (UNII: 7GXZ3858RY)
LEVOMENOL (UNII: 24WE03BX2T)
CALCIUM SODIUM PHOSPHATE (UNII: 7850XT8YDT)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
NIACINAMIDE (UNII: 25X51I8RD4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-621-02	1 in 1 BOX	07/12/2023
1	NDC: 75936-621-01	50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/12/2023

Labeler - Supergoop, LLC (117061743)