MINERAL SUSCREEN SPF 30- zinc oxide 19.0% cream

Mineral Suscreen SPF 30 by

Drug Labeling and Warnings

Mineral Suscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Vivant Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 19.0%

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 use

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 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

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

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 again. To decrease the 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.

Inactive Ingredients:

Water, Capric Caprylic Triglyceride, Lactic Acid, Mineral Oil, Isocetyl Stearoyl Stearate, Dicaprylyl Carbonate, Octyldodecanol, Glycerin, Carthamus Tinctorius (Safflower) Oleosomes, Grape Seed Oil, Glycereth 26, Sorbitan Sesquioleate, Propylene Glycol, Cetyl Alcohol, Emulsifying Wax NF, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Vitamin E Acetate, Saccharomyces/Zinc Ferment, Aloe Barbadensis Leaf Powder, Phenoxyethanol, Caprylyl Glycol, Potassium Sorbate, Hexylene Glycol, Sodium Acrylates Copolymer, Lecithin, Triethanolamine

Mineral Sunscreen SPF 30

INGREDIENTS AND APPEARANCE

MINERAL SUSCREEN SPF 30 
zinc oxide 19.0% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63750-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22400 mg  in 118.3 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
LACTIC ACID (UNII: 33X04XA5AT)
MINERAL OIL (UNII: T5L8T28FGP)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
OCTYLDODECANOL (UNII: 461N1O614Y)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GLYCERETH-26 (UNII: NNE56F2N14)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
YEAST (UNII: 3NY3SM6B8U)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LAURETH-7 (UNII: Z95S6G8201)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63750-037-04	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2020

Labeler - Vivant Pharmaceuticals, LLC (782696814)

Registrant - Vivant Pharmaceuticals, LLC (782696814)