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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Play 100% Mineral Lotion Broad Spectrum Sunscreen SPF 50

Active Ingredients Purpose

Titanium Dioxide 2% Sunscreen

Zinc Oxide 24% Sunscreen

Uses

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

Apply liberally 15 minutes before sun exposure
Reapply:

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:

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

Play 100% Mineral Lotion

with green Algae

Broad Spectrum Sunscreen SPF 50

Water Resistant (80 Minutes)

mineral lotion

PLAY MINERAL BROAD SPECTRUM SPF 50 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX (UNII: D072FFP9GU)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-175-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/16/2019
2NDC:75936-175-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product05/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/16/2019
Labeler - Supergoop, LLC (117061743)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories967781555manufacture(75936-175)

Revised: 10/2022
Document Id: ec08a129-8923-6b5a-e053-2995a90a5d4a
Set id: 89088ac5-f1ee-1996-e053-2a95a90a8fdc
Version: 3
Effective Time: 20221027
 
Supergoop, LLC