MINERAL SUNSCREEN- zinc oxide spf 50 lotion

Mineral Sunscreen by

Drug Labeling and Warnings

Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by ALAINA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc Oxide 15%

Purpose

Sunscreen

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.

Warnings

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes.

Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

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.

Directions

• Shake well.
• Apply liberally 15 minutes before sun exposure.
• Reapply:
  • After 40 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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

Aqua, Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Dibutyl Adipate, C12-15 Alkyl Benzoate, Glycerin, Polyester-7, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Squalane, VP/Eicosene Copolymer, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Asparagus Racemosus (Asparagus) Root Extract, Picrorhiza Kurroa (Picrorhiza) Root Extract, Cyperus Rotundas (Nut Grass) Root Extract, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Sodium EDTA, Tocopherol, Tocotrienols, Ectoin.

Other Information

Protect this product from excessive heat and direct sun.

Questions?

Email us at or visit

PRINCIPAL DISPLAY PANEL

Mineral Sunscreen Broad Spectrum SPF 50 PA++++ 5 mL/0.17 fl.OZ

Mineral Sunscreen Broad Spectrum SPF 50 PA++++ 50 mL/1.7 fl.OZ

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN 
zinc oxide spf 50 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73492-152
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SQUALANE (UNII: GW89575KF9)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
ASPARAGUS RACEMOSUS ROOT (UNII: Y8P1YR4920)
PICRORHIZA KURROA ROOT (UNII: ZB5K2O2999)
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOTRIENOLS (UNII: KP2MW85SSQ)
ECTOIN (UNII: 7GXZ3858RY)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73492-152-50	1 in 1 CARTON	03/07/2025
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 73492-152-05	1 in 1 CARTON	03/07/2025
2		5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/04/2025

Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)

Establishment
Name	Address	ID/FEI	Business Operations
ALAINA HEALTHCARE PRIVATE LIMITED		858720927	manufacture(73492-152)