Drug labels

Protective Tinted 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
18e1edd9-e39b-c91f-e063-6394a90a32a0
ID
18e1edd9-e39c-c91f-e063-6394a90a32a0
Effective time
20240520
Version
1
SPL product data elements

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

Warnings
Warnings For external use only
Do not use
Do not use on damaged or broken skin
When using
In case of contact with eyes, rinse with water If rash occurs, stop use and consult a doctor
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 Use daily after cleanser or serum for protective moisture and younger-looking skin. Apply to face and neck liberally 15 minutes before sun exposure. Reapply at least every two hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 sleeve shirts, pants, hats and sunglasses Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor

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.

Other safety information
Other information ■ Protect this product from excessive heat and direct sun
Questions
Questions or comments? Call toll free 1-866-JUNEJACOBS ■ www.JUNEJACOBS.com
Package label principal display panel
Protective tinted Carton Protective tinted Tube
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30
Generic name
TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer name
June Jacobs Labs LLC
Product NDC
65278-104
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE, TITANIUM DIOXIDE
SPL ID
18e1edd9-e39c-c91f-e063-6394a90a32a0
SPL set ID
18e1edd9-e39b-c91f-e063-6394a90a32a0
Package NDC
65278-104-01, 65278-104-02
Is original packager
true
UNII
SOI2LOH54Z, 15FIX9V2JP
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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.