MINERAL SUNSCREEN- zinc oxide 20% lotion

Mineral Sunscreen by

Drug Labeling and Warnings

Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by The Daily Suncare LLC, DBA Daily Shade. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 20%

DOSAGE & ADMINISTRATION

Topical Lotion

PURPOSE

Sunscreen

INDICATIONS & USAGE

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.

INSTRUCTIONS FOR USE

Apply generously and evenly 15 minutes before sun exposure. Apply to all skin exposed to the sun at least every 2 hours. Reapply after 40 minutes of swimming or sweating. Children under 6 months of age: ask a doctor.

Sun Protection Measures: Spending time in the sun increases 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 highre and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long-sleeved shirts, pants, hats, and sunglasses.

WARNINGS

For external use only. 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.

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

Stop use and ask a doctor if rash occurs.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

ASK DOCTOR

Stop use and ask a doctor if rash occurs. Children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Aqua/Water/Eau, Caprylic/Capric Triglyceride, Undecane, Isoamyl Laurate, Polyglyceryl-6 Polyhydroxystearate, Tridecane, Glycerin, Magnesium Sulfate, Octyldodecyl Stearoyl Stearate, Polyglyceryl-6 Polyricinoleate,Brassica Napus Extract, Stearalkonium Bentonite, Triethyl Citrate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Polyhydroxystearic Acid, Bixa Orellana Leaf Extract, Deoxyribonuclease, Glucose Oxidase, Jacaranda Mimosifolia Flower Extract, Kalanchoe Pinnata Leaf Extract, Raspberry Ketone, Sodium Citrate, Xanthan Gum, Squalane, Jojoba Esters, Polyglyceryl-3 Diisostearate, Stearoyl Glutamic Acid, Mica, Triethoxycaprylylsilane, Tocopherol, Iron Oxides

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN 
zinc oxide 20% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84380-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
UNDECANE (UNII: JV0QT00NUE)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
JACARANDA MIMOSIFOLIA WHOLE (UNII: L0Y00LQX0R)
MICA (UNII: V8A1AW0880)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TRIDECANE (UNII: A3LZF0L939)
KALANCHOE PINNATA WHOLE (UNII: D2TTE8F2Z3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
WATER (UNII: 059QF0KO0R)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
BIXA ORELLANA LEAF (UNII: KQ341J3HXI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
STEARALKONIUM BENTONITE (UNII: AH5EVE6GTY)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84380-001-90	90 g in 1 TUBE; Type 0: Not a Combination Product	06/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/07/2024

Labeler - The Daily Suncare LLC, DBA Daily Shade (061349979)