FDA.reportPublic FDA data

Mineral Suscreen SPF 30

Manufacturer
Vivant Pharmaceuticals, LLC
Effective date
2025-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:33

Label at a glance#

ProductMineral Suscreen SPF 30
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

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 su...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

OTC - STOP USE SECTION

rash or irritation develops and lasts

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

PouchPouch

BottleBottle

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63750-038-01Mineral Suscreen SPF 3030 g in 1 BOTTLECREAM301
63750-038-03Mineral Suscreen SPF 3089 g in 1 BOTTLECREAM891

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63750-03863750-038-01, 63750-038-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
YEAST, UNSPECIFIED3NY3SM6B8UIACT
CETEARYL ALCOHOL2DMT128M1SIACT
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
PEG-100 STEARATEYD01N1999RIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
GLYCERYL STEARATE230OU9XXE4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ZINC OXIDESOI2LOH54ZACTIB
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
GRAPE SEED OIL930MLC8XGGIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYSORBATE 60CAL22UVI4MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Suscreen SPF 30ZINC OXIDE 19.0%Vivant Pharmaceuticals, LLC3aadb658-d12d-ae8d-e063-6394a90a64962025-07-24WarningsExact identifier
ndc (package): 63750-038-01
ndc (package): 63750-038-03
ndc (product): 63750-038
ndc11 (package): 63750003801
ndc11 (package): 63750003803
spl id: 3aadc382-e2ec-019e-e063-6394a90a45c3
spl set id: 3aadb658-d12d-ae8d-e063-6394a90a6496

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.