Label: SIMPLE TRUTH MINERAL BASED SPF 30 SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 30142-812-15
- Packager: THE KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 9, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- INDICATIONS & USAGE
- Warnings
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMPLE TRUTH MINERAL BASED SPF 30 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-812 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) OAT (UNII: Z6J799EAJK) JOJOBA OIL (UNII: 724GKU717M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBITAN TRISTEARATE (UNII: 6LUM696811) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN (UNII: L7HT8F1ZOD) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) POLYSORBATE 60 (UNII: CAL22UVI4M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-812-15 177 mL in 1 TUBE; Type 0: Not a Combination Product 09/26/2018 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)
