MINERAL SUNSCREEN SPF 50- zinc oxide cream

Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

Mineral Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Better Planet Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 22%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

For external use

Do not use on damaged or broken skin.

When using the 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 product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Directions_ apply liberally 15 minutes before sun exposure

reapply at least every 2 hours
use a water-resistant sunscreen if swimming or sweating. 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

Other information

Protect this product from excessive heat and direct sun.
May stain some

Inactive Ingredients

ALOE BARBADENSIS LEAF JUICE*, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYESTER-8, GLYCERIN, WATER, CETEARYL ALCOHOL, GLYCERYL STEARATE, SQUALANE, ISOAMYL LAURATE, SORBITAN SESQUIOLEATE, TOCOPHEROL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, HELANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM HYALURONATE, HYDROLYZED JOJOBA ESTERS, BISABOLOL, PULLULAN, SCLEROTIUM GUM, XANTHAN GUM, GLYCOLIPIDS, GLYCERYL CAPRYLATE, SODIUM STEAROYL GLUTAMATE, POLYHYDROXYSTEARIC ACID, COCO-GLUCOSIDE, LYSOLECITHIN, SILICA, CAPRYLHYDROXAMIC ACID, CITRIC ACID

Questions?

Call toll-free 877.902.2873

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54136-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
ACENEURAMIC ACID (UNII: GZP2782OP0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
WATER (UNII: 059QF0KO0R)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
PULLULAN (UNII: 8ZQ0AYU1TT)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCO-GLUCOSIDE (UNII: ICS790225B)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SQUALANE (UNII: GW89575KF9)
JOJOBA OIL (UNII: 724GKU717M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54136-351-92	92 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2024

Labeler - Better Planet Brands LLC (960253719)