YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM

Manufacturer
MANA Products, Inc. | MANA Products,Inc.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:42

Label at a glance#

ProductYOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure10 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use 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 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: Limi...

Label contents#

Full prescribing information#

Actives

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Titanium Dioxide 5.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen active

USE

OTC - WHEN USING 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 on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 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 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Butylene Glycol, Titanium Dioxide, Zinc Oxide, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Tocopherol, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Magnesium Ascorbyl Phosphate, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Lysine, Aluminum Hydroxide, Disodium EDTA, Hexylene Glycol, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

MAY CONTAIN (+/-):

Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label-cartonLabel-cartonPDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-186-01YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM36 mL in 1 BOTTLECREAM362
59735-186-01YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-186YOUR NAME TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM (YOUR NAME TINTED PRIMER) CREAM [MANA PRODUCTS, INC.]22 package rows20240106_0e36fbea-e97a-33ad-e063-6394a90a8078.zip

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59735-18659735-186-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e36f174-0355-37ad-e063-6394a90a29b60e36fbea-e97a-33ad-e063-6394a90a80782024-01-05WarningsExact identifier
spl id: 0e36f174-0355-37ad-e063-6394a90a29b6
spl set id: 0e36fbea-e97a-33ad-e063-6394a90a8078

Reported adverse events (FAERS/openFDA)#

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