Drug labels

Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30

TITANIUM DIOXIDE, ZINC OXIDE · June Jacobs Labs, LLC · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
18e4c50d-eb91-c269-e063-6394a90a7999
ID
18e4c50d-eb92-c269-e063-6394a90a7999
Effective time
20240520
Version
1
SPL product data elements

Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide ETHYL MACADAMIATE ORANGE OIL LAUROYL LYSINE ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE COCO-CAPRYLATE/CAPRATE GERANIUM OIL, ALGERIAN TYPE AVOCADO OIL TITANIUM DIOXIDE TITANIUM DIOXIDE TOCOPHEROL ALUMINUM OXIDE SACCHAROMYCES CEREVISIAE OCTYLDODECYL ERUCATE SUNFLOWER OIL GLYCERYL CAPRYLATE AMYRIS BALSAMIFERA OIL VETIVER OIL STEARIC ACID SHEA BUTTER GLYCERIN GLYCERYL 1-UNDECYLENATE MALIC ACID CASTOR OIL LINALOOL, (+/-)- GALBANUM DILINOLEIC ACID/BUTANEDIOL COPOLYMER GREEN TEA LEAF PUNICA GRANATUM ROOT BARK CANDELILLA WAX LAVANDIN OIL POLYGLYCERYL-6 POLYRICINOLEATE VITIS VINIFERA SEED LYCIUM BARBARUM FRUIT CITRAL LITSEA OIL POGOSTEMON CABLIN LEAF OIL GINGER OIL ASPALATHUS LINEARIS LEAF LIMONENE, (+)- BEHENYL BEHENATE POLYHYDROXYSTEARIC ACID (2300 MW) JUNIPER BERRY OIL FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) Nude/Beige

Active ingredient
Active Ingredients Titanium Dioxide................4.31% Zinc Oxide .......................19.27%
Purpose
Sunscreen
Indications and usage

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 cause by the sun.

Warnings
Warnings For external use only
Do not use
Do not use on damaged or broken skin
When using
When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage and administration

Directions • Apply liberally 15 minutes before sun exposure • Reapply every 2 hours • Use a water resistant sunscreen if swimming or sweating • Children under 6 months of age: 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 safety information
Other information • Protect the product in this container from excessive heat and direct sun
Inactive ingredient

Inactive ingredients Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco-Caprylate/Caprate, Behenyl Behenate, Sorbitol/ Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.

Questions
Questions or comments? Call toll free 1-866-586-3522
Package label principal display panel
Mineral Sun Defense carton Mineral Sun Defense Tube
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30
Generic name
TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer name
June Jacobs Labs, LLC
Product NDC
65278-619
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
TITANIUM DIOXIDE, ZINC OXIDE
SPL ID
18e4c50d-eb92-c269-e063-6394a90a7999
SPL set ID
18e4c50d-eb91-c269-e063-6394a90a7999
Package NDC
65278-619-01, 65278-619-02
Is original packager
true
UNII
15FIX9V2JP, SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.