PLAY MINERAL SUNSCREEN SPF-50- titanium dioxide, zinc oxide lotion

Play Mineral Sunscreen by

Drug Labeling and Warnings

Play Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by TUBBY TODD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 5%
Zinc Oxide 7%

PURPOSE

SUNSCREEN

USES

helps prevent sunburn.
if used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

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.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply generously 15 minutes before sun exposure and as needed.
reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: ask a doctor
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 time in the sun, especially from 10 a.m.-2 p.m. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses".

OTHER INFORMATION

Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Alkyl Benzoate, Benzoic Acid, C12-C15, Caprylic Capric Triglycerides, Cetyl PEG/PPG-10/1 Dimethicone, Crosspolymer, Dicaprylyl ether, Ethylhexylglycerin, Glycereth-2 Cocoate, Glycerin, Isostearic Acid, Octyldodecyl Stearoyl Citrate, Phenoxyethanol, Polyhydroxystearic Acid, Propanediol, Sodium Chloride, Sodium Hyaluronate, Triethoxycaprylylsilane, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PLAY MINERAL SUNSCREEN  SPF-50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
ISOSTEARIC ACID (UNII: X33R8U0062)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73088-101-14	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/21/2019

Labeler - TUBBY TODD (052545299)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty		794053863	manufacture(73088-101)