FDA.reportPublic FDA data

Surya Natural Mineral Sunscreen

Manufacturer
Hale Cosmeceuticals
Effective date
2022-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:48:27

Label at a glance#

ProductSurya Natural Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

• Apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: Ask a doctor. • 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 measu...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

• For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin

Stop use and ask a doctor 

OTC - STOP USE SECTION

• if rash occurs

When using this product

OTC - WHEN USING SECTION

• keep out of eyes. • Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: Ask a doctor. • 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

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun • may stain some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

• Caprylic/Capric Triglyceride, Persea Gratissima (Avocado) Oil, Beeswax, Cocos Nucifera (Coconut) Oil, Soybean Glycerides, Shea Butter Unsaponificables, Tocopheryl Acetate, Bisabolol, Butyrospermum Parkii (Shea) Butter, Sesamum Indicum (Sesame) Seed Oil, Emblica Officinalis Fruit Extract, Curcumin, Copernicia Cerifera (Carnauba) Wax, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrobisdemethoxydiferuloylmethane, Potassium Cocoate, Tetrahexyldecyl Ascorbate, Fragrance.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71987-00971987-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
AVOCADO OIL6VNO72PFC1IACT
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEVOMENOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
SESAME OILQX10HYY4QVIACT
PHYLLANTHUS EMBLICA FRUITYLX4CW2576IACT
CURCUMINIT942ZTH98IACT
CARNAUBA WAXR12CBM0EIZIACT
TETRAHYDRODIFERULOYLMETHANE00U0645U03IACT
TETRAHYDRODEMETHOXYDIFERULOYLMETHANE44D8X9U00TIACT
TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE973IBV8W7IIACT
POTASSIUM COCOATEF8U72V8ZXPIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ZINC OXIDESOI2LOH54ZACTIM

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
ed231fc9-06df-261b-e053-2a95a90a063c03db613d-09de-4c06-a52c-feecdfd500c62022-11-10WarningsExact identifier
spl id: ed231fc9-06df-261b-e053-2a95a90a063c
spl set id: 03db613d-09de-4c06-a52c-feecdfd500c6

Reported adverse events (FAERS/openFDA)#

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