FDA.reportPublic FDA data

SPF Rx - Mineral Sunscreen SPF 30

Manufacturer
Cal Pharma LLC | Health Specialty
Effective date
2017-07-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:14:29

Label at a glance#

ProductSPF Rx - Mineral Sunscreen SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer, early skin aging by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: - After 80 minutes of swimming or sweating - At least every 2 hours. Immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in th...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 5%

Titanium Dioxide 3%

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, early skin aging by the sun.

WARNINGS

WARNINGS SECTION

For external use only. 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 a doctor if rash occurs.

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply:

- After 80 minutes of swimming or sweating

- At least every 2 hours. Immediately after towel drying.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months. Ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Benzoic Acid, C12-15 Alkyl Benzoate, Caprylic/Capric Triglycerides, Cetyl PEG/PPG-10/1 Dimethicone, Dicaprylyl Ether, Ethylhexylglycerin, Glycereth-2 Cocoate, Glycerin, Isostearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Propanediol, Sodium Chloride, Sodium Hyaluronate, Tocopheryl Acetate (Vitame E Acetate), Triethoxycaprylylsilane, Water.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label_Mineral SPF 30_Primary 4ozLabel_Mineral SPF 30_Primary 4oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55628-8569-42024-03-28C16284748780-1d6a99b39-cffa-a426-e053-dadaa90af4c299053ff8-2e52-4c14-b5f8-49957f910a70
55628-8569-42022-01-28C16284748780-1d6a99b39-cffa-a426-e053-dadaa90af4c299053ff8-2e52-4c14-b5f8-49957f910a70

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55628-856955628-8569-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
BENZOIC ACID8SKN0B0MIMIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
DICAPRYLYL ETHER77JZM5516ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
GLYCERINPDC6A3C0OXIACT
ISOSTEARIC ACIDX33R8U0062IACT
OCTYLDODECYL STEARATEK6F16QGO28IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
14c275cc-7662-efed-e063-6394a90a747199053ff8-2e52-4c14-b5f8-49957f910a702024-03-28WarningsExact identifier
spl set id: 99053ff8-2e52-4c14-b5f8-49957f910a70

Reported adverse events (FAERS/openFDA)#

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