Simple Truth Mineral Based Spf 50 Sunscreen Lotion

Simple Truth Mineral Based Spf 50 Sunscreen Lotion
SPL v3
SPL
SPL Set ID a52872bf-cd0f-06da-e053-2995a90af28d
Route
TOPICAL
Published
Effective Date 2018-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (30 mg) Zinc Oxide (150 mg)
Inactive Ingredients
Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Oat Jojoba Oil Ethylhexylglycerin Anhydrous Citric Acid Water Butyloctyl Salicylate Arachidyl Glucoside Stearyl Alcohol Sorbitan Tristearate Silicon Dioxide Vinylpyrrolidone/hexadecene Copolymer Aloe Vera Leaf Soybean Arachidyl Alcohol Docosanol Tocopherol Magnesium Sulfate Heptahydrate Glycerin Glyceryl 1-stearate Polysorbate 60 Medium-chain Triglycerides Stearyl/octyldodecyl Citrate Crosspolymer Neopentyl Glycol Diheptanoate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-20

Description

Titanium Dioxide 3.0%, Zinc Oxide 15.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.0%, Zinc Oxide 15.0%

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
Label

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure

  • reapply:
  • after 80 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
Do Not Use
  • on damaged or broken skin.
Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Titanium Dioxide 3.0%, Zinc Oxide 15.0%

Inactive Ingredients

water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/ MA copolymer, sorbitan tristearate, silica, stearyl/octyldodecyl citrate crosspolymer, VP/hexadecene copolymer, phenoxyethanol, magnesium sulfate, citric acid, glycerin, stearyl alcohol, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, ethylhexylglycerin, aloe barbadensis leaf juice, avena sativa (oat) kernel extract, glycine soja (soybean) seed extract, tocopherol.

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.


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
Label

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure

  • reapply:
  • after 80 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
Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients (Active ingredients)

Titanium Dioxide 3.0%, Zinc Oxide 15.0%

Inactive Ingredients (Inactive ingredients)

water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/ MA copolymer, sorbitan tristearate, silica, stearyl/octyldodecyl citrate crosspolymer, VP/hexadecene copolymer, phenoxyethanol, magnesium sulfate, citric acid, glycerin, stearyl alcohol, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, ethylhexylglycerin, aloe barbadensis leaf juice, avena sativa (oat) kernel extract, glycine soja (soybean) seed extract, tocopherol.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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.


Advanced Ingredient Data


Raw Label Data

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