PLAY MINERAL BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion

Play Mineral Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Play Mineral Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Titanium Dioxide 2% Sunscreen

Zinc Oxide 24% 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.

WARNINGS

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

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 a Broad Spectrum SPF value 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10a.m. – 2p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

C9-12 Alkane, Caprylic/Capric Triglyceride, Cetyl Esters, Coco-Caprylate/Caprate, Haematococcus Pluvalis Extract, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Hydrogenated Rapeseed Oil, Hydrolyzed Jojoba Esters, Isopropyl Palmitate, Jojoba Esters, Perilla Ocymoides (Perilla) Seed Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Seed Oil, Sea Water, Silica, Stearic Acid, Water

PRINCIPAL DISPLAY PANEL

Play 100% Mineral Lotion

with green Algae

Broad Spectrum Sunscreen SPF 50

Water Resistant (80 Minutes)

INGREDIENTS AND APPEARANCE

PLAY MINERAL BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-175-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019
2	NDC: 75936-175-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/16/2019

Labeler - Taylor James Ltd (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES,INC		008328619	manufacture(75936-175)