Tinted Sunscreen Cream Spf 30 4-deep Amber

Tinted Sunscreen Cream Spf 30 4-deep Amber
SPL v6
SPL
SPL Set ID 5599922a-b020-477c-a44c-1db42ec5756a
Route
TOPICAL
Published
Effective Date 2017-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (129.3 mg) Zinc Cation (108.9 mg)
Inactive Ingredients
Water Caprylyl Trisiloxane Glycerin Polyglyceryl-3 Diisostearate Silicon Dioxide Shea Butter Polyglyceryl-4 Isostearate Hexyl Laurate Camellia Oil Sodium Chloride .alpha.-tocopherol Acetate Mango Thymus Mastichina Flowering Top Oil Sage Oil Aluminum Oxide Dimethicone Hydrogenated Soybean Lecithin Edetate Disodium Anhydrous Glyceryl Monocaprylate Ethylhexylglycerin Triethoxycaprylylsilane Citric Acid Monohydrate Sodium Citrate, Unspecified Form Benzoic Acid Sodium Benzoate Potassium Sorbate Ferric Oxide Red Linalool, (+/-)- Limonene, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-15

Description

Titanium dioxide 12.93% Zinc oxide 10.89%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 12.93% Zinc oxide 10.89%

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

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

Directions
  • 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.
  • ​ Spending time in the sun increases your risk of skin cancern and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ​Sun Protection Measures.

    • Limit time in the sun, especially from 10 am to 2 pm.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
Package Labeling

Other Information

Protect the product in the container from excessive heat or direct sun.

Active Ingredients

Titanium dioxide 12.93%

Zinc oxide 10.89%

Inactive Ingredients

water, c9- 12 alkane, caprylyl methicone, glycerin, polyglyceryl-3 diisostearate, silica, butyrospermum parkii (shea) butter, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, camellia oleifera seed oil, sodium chloride, tocopheryl acetate, leontopodium alpinum extract, mangifera indica (mango) fruit extract, thymus mastichina flower oil, salvia officinalis (sage) oil, alumina, dimethicone, hydrogenated lecithin, disodium edta, glyceryl caprylate, ethylhexyglycerin, synthetic fluorphlogopite, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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.
Purpose

Sunscreen

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

Directions
  • 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.
  • ​ Spending time in the sun increases your risk of skin cancern and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ​Sun Protection Measures.

    • Limit time in the sun, especially from 10 am to 2 pm.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
Package Labeling (Package labeling)

Other Information (Other information)

Protect the product in the container from excessive heat or direct sun.

Active Ingredients (Active ingredients)

Titanium dioxide 12.93%

Zinc oxide 10.89%

Inactive Ingredients (Inactive ingredients)

water, c9- 12 alkane, caprylyl methicone, glycerin, polyglyceryl-3 diisostearate, silica, butyrospermum parkii (shea) butter, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, camellia oleifera seed oil, sodium chloride, tocopheryl acetate, leontopodium alpinum extract, mangifera indica (mango) fruit extract, thymus mastichina flower oil, salvia officinalis (sage) oil, alumina, dimethicone, hydrogenated lecithin, disodium edta, glyceryl caprylate, ethylhexyglycerin, synthetic fluorphlogopite, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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