FDA.reportPublic FDA data

SPF30

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:47

Label at a glance#

ProductSPF30
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. Used as directed with other sun proctection measures, decreases skin cancer risk and early skin aging, caused by the sun.

Dosage and administration

Applying 15 minutes before sun exposure Using a water resistant sunscreen if swimming or sweating Reapplying at least every 2 hours For children under 6 months: consult pediatrician

Storage and handling

Keep out of direct sunlight and excessive heat. Some natural seperation may occur. Shake well before using.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sun Alert:

ALARMS

Limiting sun exposure, wearing protective clothing, and using broad spectrum sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Used as directed with other sun proctection measures, decreases skin cancer risk and early skin aging, caused by the sun.

Caution

STORAGE AND HANDLING SECTION

Keep out of direct sunlight and excessive heat. Some natural seperation may occur. Shake well before using.

Warnings

WARNINGS SECTION

For external use only. Do not ingest. Keep out of eyes; rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact poison control.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat or direct sun.

Directions: FDA Recommends

DOSAGE & ADMINISTRATION SECTION

  • Applying 15 minutes before sun exposure
  • Using a water resistant sunscreen if swimming or sweating
  • Reapplying at least every 2 hours
  • For children under 6 months: consult pediatrician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Beeswax, Butyrospermum parkii (Shea) Butter, C12-15 Alkyl Benzoate, Candelilla (Euphorbia Cerifera) Wax, Carthamus tinctorius (Safflower) Seed Oil, Chamomilla recutita (Matricaria) Flower Extract, Cocos nucifera (Coconut) Oil, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus annuus (Sunflower) Seed Oil, Lavandula angustifolia (Lavender) Oil, Mangifera indica (Mango) Seed Butter, Olea europaea (Olive) Fruit Oil, Persea gratissima (Avocado) Oil, Symphytum officinale (Comfrey) Leat Extract, Theobroma cacao (Cocoa) Seed Butter, Tocopherol, Triethoxycaprylylsiloxane

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-652-352024-01-30C16284748780-11030e365-3411-111a-e063-dadaa90a10e2cffd82fe-c05a-58df-e053-2995a90acd21

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-652-35SPF30100 mL in 1 TUBELOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-652SPF30 (ZINC OXIDE) LOTION [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 1 package rows20211106_cffd82fe-c05a-58df-e053-2995a90acd21.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-65258133-652-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
COCOA BUTTER512OYT1CRRIACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
OLIVE OIL6UYK2W1W1EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CHAMOMILEFGL3685T2XIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SHEA BUTTERK49155WL9YIACT
AVOCADO OIL6VNO72PFC1IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SUNFLOWER OIL3W1JG795YIIACT
ALMOND OIL66YXD4DKO9IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CANDELILLA WAXWL0328HX19IACT
LAVENDER OILZBP1YXW0H8IACT
ALOE VERA LEAFZY81Z83H0XIACT
COMFREYD05HXK6R3GIACT
ZINC OXIDESOI2LOH54ZACTIB

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
cffd766c-cc70-1be0-e053-2995a90a2dbbcffd82fe-c05a-58df-e053-2995a90acd212021-11-04WarningsExact identifier
spl id: cffd766c-cc70-1be0-e053-2995a90a2dbb
spl set id: cffd82fe-c05a-58df-e053-2995a90acd21