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.

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

rash or irritation develops and lasts

Inactive Ingredients:

aloe barbadensis leaf juice, C13-14 isoparaffin, caprylic/capric triglyceride, capryloyl glycerin/sebacic acid copolymer, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, diheptyl succinate, emulsifying wax, glycerin, glyceryl stearate, hexylene glycol, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, polyhydroxystearic acid, potassium sorbate, saccharomyces/zinc ferment, sorbitan sesquioleate, tocopheryl acetate, vitis vinifera (grape) seed oil, water

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. If pregnant or breastfeeding, ask a health professional before use.

Directions

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

Children under 6 months of age: ask a doctor.

Use enough to cover your entire face and body (avoiding the eyes and mouth)

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUSCREEN SPF 30 
zinc oxide 19.0% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63750-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63750-038-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2025
2	NDC: 63750-038-03	89 g in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/01/2025

Labeler - Vivant Pharmaceuticals, LLC (782696814)

Registrant - Vivant Pharmaceuticals, LLC (782696814)