SIMPLE TRUTH MINERAL BASED SPF 30 SUNSCREEN: Package Insert and Label Information

SIMPLE TRUTH MINERAL BASED SPF 30 SUNSCREEN- titanium dioxide and zinc oxide lotion
THE KROGER COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Titanium Dioxide 3.0%, Zinc Oxide 10.0%

Purpose

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

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.

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 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

Other information

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

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, aloe barbadensis leaf juice, glycine soja (soybean) seed extract, glycerin, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, stearyl alcohol, tocopherol, avena sativa (oat) kernel extract, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, ethylhexylglycerin, citric acid

Questions or comments?

Call toll free 1-800-632-6900

SIMPLE TRUTH MINERAL BASED SPF 30 SUNSCREEN LOTION

Label
(click image for full-size original)
SIMPLE TRUTH MINERAL BASED SPF 30 SUNSCREEN
titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-812
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 30 mg in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
OAT
JOJOBA OIL
ETHYLHEXYLGLYCERIN
CITRIC ACID MONOHYDRATE
WATER
BUTYLOCTYL SALICYLATE
ARACHIDYL GLUCOSIDE
STEARYL ALCOHOL
PHENOXYETHANOL
SORBITAN TRISTEARATE
SILICON DIOXIDE
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)
ALOE VERA LEAF
SOYBEAN
ARACHIDYL ALCOHOL
DOCOSANOL
.ALPHA.-TOCOPHEROL, DL-
MAGNESIUM SULFATE HEPTAHYDRATE
GLYCERIN
GLYCERYL 1-STEARATE
POLYSORBATE 60
MEDIUM-CHAIN TRIGLYCERIDES
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER
NEOPENTYL GLYCOL DIHEPTANOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-812-15 177 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/26/2018
Labeler — THE KROGER COMPANY (006999528)

Revised: 02/2021 THE KROGER COMPANY

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