Label: TINTED MOISTURIZER SPF 30 SPF 30- octinoxate, titanium dioxide, zinc oxide cream
- NDC Code(s): 71692-001-35
- Packager: Regi U.S. Inc
- 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 January 6, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
• apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 sun, especially from 10 a.m.- 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor
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Inactive Ingredients
Purified Water, Cyclopentasiloxane, Isononyl Isononanoate, Phenyl Trimethicone, Alcohol Denat., Lauryl PEG-8 Dimethicone, Disteardimonium Hectorite, Sodium Chloride, PEG-10 Dimethicone, Talc, Caprylyl Glycol, Alumina, Stearic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Dehydroacetate, Methicone, Hexylene Glycol, Propanediol, Tocopheryl Acetate, Hydrogen Dimethicone, Boerhavia Diffusa Root Extract, Ascorbyl Palmitate MAY CONTAIN: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)
- Other information
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- Package Label
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INGREDIENTS AND APPEARANCE
TINTED MOISTURIZER SPF 30 SPF 30
octinoxate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71692-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALCOHOL (UNII: 3K9958V90M) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TALC (UNII: 7SEV7J4R1U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM OXIDE (UNII: LMI26O6933) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHICONE (20 CST) (UNII: 6777U11MKT) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PROPANEDIOL (UNII: 5965N8W85T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL) ASCORBYL PALMITATE (UNII: QN83US2B0N) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71692-001-35 35 g in 1 TUBE; Type 0: Not a Combination Product 09/08/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/08/2017 Labeler - Regi U.S. Inc (080161899) Establishment Name Address ID/FEI Business Operations Regi U.S. Inc 080161899 manufacture(71692-001)
