Label: PLAY MINERAL BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 75936-175-01, 75936-175-02
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 27, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
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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
-
INGREDIENTS AND APPEARANCE
PLAY MINERAL BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide lotionProduct 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) 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 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 - Supergoop, LLC (117061743) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(75936-175)
