PLAY BODY MOUSSE WITH BLUE SEA KALE BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate cream

Play Body Mousse with Blue Sea Kale Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Play Body Mousse with Blue Sea Kale Broad Spectrum SPF 50 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 Purpose

Avobenzone3% Sunscreen

Homosalate 15% Sunscreen

Octisalate 5% Sunscreen

PURPOSE

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.

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

INDICATIONS & USAGE

Stop use and ask a doctor if

rash occurs or irritation develops and lasts.

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

DOSAGE & ADMINISTRATION

Apply generously and evenly 15 minutes before sun exposure
Use a water-resistant sunscreen if swimming or sweating
Reapply 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 a Broad-Spectrum SPF value of 15 or higher and other sun
protection measures including: limit your time in the sun, especially from 10
a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Aluminum Starch Octenylsuccinate, Ananas Sativus (Pineapple) Fruit Extract, Bis-Hydroxyethoxypropyl Dimethicone,Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Cananga Odorata Flower Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera (Coconut) Fruit Extract, Cocos Nucifera (Coconut) Oil, Coffea Arabica (Coffee) Seed Extract, Crambe Maritima Leaf Extract, Cucumis Melo Cantalupensis Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Olea Europaea (Olive) Fruit Oil, Panthenol, Passiflora Incarnata Fruit Extract, Persea Gratissima (Avocado) Oil, Polyester-5, Potassium Cetyl Phosphate, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Rubus Idaeus (Raspberry) Fruit Extract, Santalum Album (Sandalwood) Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Trehalose, Vanilla Planifolia Fruit Extract, Water

PRINCIPAL DISPLAY PANEL

Supergoop!

PLAY

SPF 50

Body Mousse With Blue Sea Kale

Broad Spectrum Suncreen SPF 50

Water and Sweat Resistant (80 minutes)

84 ml e 86 g 3.0 oz

INGREDIENTS AND APPEARANCE

PLAY BODY MOUSSE WITH BLUE SEA KALE BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AVOCADO OIL (UNII: 6VNO72PFC1)
APPLE (UNII: B423VGH5S9)
COCONUT (UNII: 3RT3536DHY)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
VANILLA BEAN (UNII: Q74T35078H)
CANTALOUPE (UNII: 8QF5D5H6UH)
CUCUMBER (UNII: YY7C30VXJT)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALMOND (UNII: 3Z252A2K9G)
RASPBERRY (UNII: 4N14V5R27W)
TREHALOSE (UNII: B8WCK70T7I)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
POLYESTER-5 (TG-48) (UNII: 791E7S99Q2)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SANDALWOOD (UNII: 3641YW25N2)
COCOA (UNII: D9108TZ9KG)
PUMMELO (UNII: ET1TN5W71X)
SHEA BUTTER (UNII: K49155WL9Y)
LEMON PEEL (UNII: 72O054U628)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHLORPHENESIN (UNII: I670DAL4SZ)
ORANGE PEEL (UNII: TI9T76XD44)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
PANTHENOL (UNII: WV9CM0O67Z)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
APRICOT (UNII: 269CJD5GZ9)
JOJOBA OIL (UNII: 724GKU717M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCONUT OIL (UNII: Q9L0O73W7L)
CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALMOND OIL (UNII: 66YXD4DKO9)
PINEAPPLE (UNII: 2A88ZO081O)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-227-01	84 mL in 1 CAN; Type 0: Not a Combination Product	04/02/2020
2	NDC: 75936-227-02	181 mL in 1 CAN; Type 0: Not a Combination Product	04/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/02/2020

Labeler - Taylor James, Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(75936-227)