PLAY EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT- avobenzone, homosalate, octisalate, octocrylene cream

Play Everyday Sunscreen SPF 50 with Sunflower Extract by

Drug Labeling and Warnings

Play Everyday Sunscreen SPF 50 with Sunflower Extract 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

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 7.5% 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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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

If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 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 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

Water, Acrylates Copolymer,  Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Camprestris/Aleurites Fordi Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Rosaeodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil,​ Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (Sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamene Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride,Panthenol, Pentasodium Triphosphate, Citric Acid

PRINCIPAL DISPLAY PANEL

Supergoop!

PLAY

SPF 50

Everyday Lotion with Sunflower Extract

Broad Spectrum SPF 50 PA++++

Water & Sweat Resistant

5.5 fl. oz./ 162 ml

INGREDIENTS AND APPEARANCE

PLAY EVERYDAY SUNSCREEN SPF 50 WITH SUNFLOWER EXTRACT 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-236
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	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
GLYCERIN (UNII: PDC6A3C0OX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ISODODECANE (UNII: A8289P68Y2)
LAURYL LACTATE (UNII: G5SU0BFK7O)
CETYL ALCOHOL (UNII: 936JST6JCN)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
RICE BRAN (UNII: R60QEP13IC)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
ROSEWOOD OIL (UNII: F2522O5L7B)
CHLORPHENESIN (UNII: I670DAL4SZ)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON OIL (UNII: I9GRO824LL)
EUCALYPTUS OIL (UNII: 2R04ONI662)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
BEHENIC ACID (UNII: H390488X0A)
CETYL BEHENATE (UNII: WFM51TRO3E)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TOCOPHEROL (UNII: R0ZB2556P8)
ALLANTOIN (UNII: 344S277G0Z)
ROSEMARY (UNII: IJ67X351P9)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-236-01	3 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2020
2	NDC: 75936-236-02	10 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2020
3	NDC: 75936-236-03	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2020
4	NDC: 75936-236-04	71 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2020
5	NDC: 75936-236-05	162 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
6	NDC: 75936-236-06	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2020

Labeler - Taylor James Ltd (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company, Inc.		620899877	manufacture(75936-236)