Drug labels

Sun Defense Minerals (Tan)

ZINC OXIDE, TITANIUM DIOXIDE · Eminence Organic Skin Care · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
2ee82379-6609-fd8e-e063-6294a90acf6c
ID
2ee80da2-7c84-f46c-e063-6294a90ac5e2
Effective time
20250224
Version
1
SPL product data elements

Sun Defense Minerals (Tan) Zinc Oxide, Titanium Dioxide PHENYLPROPANOL PROPANEDIOL MAURITIA FLEXUOSA FRUIT OIL BUTYLOCTYL SALICYLATE ZINC OXIDE ZINC OXIDE IRON OXIDES ALUMINUM HYDROXIDE TRIDECYL SALICYLATE CAPRYLYL GLYCOL HYDROGENATED SOYBEAN LECITHIN OCTYLDODECANOL TOCOPHEROL MICA TITANIUM DIOXIDE TITANIUM DIOXIDE HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL CAMELLIA SINENSIS LEAF HYDRATED SILICA

Dosage and administration

Directions Before use, shake or tap well Apply liberally 15 minutes before sun exposure Reapply After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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.

Warnings

Warnings 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredient

Inactive ingredients Silica, Mica, Iron Oxides, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

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

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.
Active ingredient
Active Ingredients Purpose Titanium Dioxide 12.8%; Zinc Oxide 23.5%......Sunscreen
Purpose
Purpose: Sunscreen
Package label principal display panel

Drug Facts Active Ingredients Purpose Titanium Dioxide 12.8%; Zinc Oxide 23.5%......Sunscreen 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 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Before use, shake or tap well Apply liberally 15 minutes before sun exposure Reapply After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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 information Protect the product in this container from excessive heat and direct sun Inactive ingredients Silica, Mica, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Iron Oxides, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin. Pro Jar Label

Harmonized identifiers (openFDA)
Application number
M020
Brand name
Sun Defense Minerals (Tan)
Generic name
ZINC OXIDE, TITANIUM DIOXIDE
Manufacturer name
Eminence Organic Skin Care
Product NDC
15751-3606
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE, TITANIUM DIOXIDE
SPL ID
2ee80da2-7c84-f46c-e063-6294a90ac5e2
SPL set ID
2ee82379-6609-fd8e-e063-6294a90acf6c
Package NDC
15751-3606-2
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.