Label: SKIN RESEARCH INSTITUTE NATURALLY BASED SUNSCREEN SPF 30- octinoxate and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66163-6504-2 - Packager: Cosmetic Solutions LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 30, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- Purpose
- USES
- WARNINGS
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DIRECTIONS
Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. *For 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.
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INACTIVE INGREDIENTS
Water (Aqua), Aloe Barbadensis Leaf Extract, Isocetyl Stearate, Sorbitol, Cetearyl Alcohol, Ceteareth-20, Tocopheryl Acetate, Acetyl Hexapeptide-8, Hydrolyzed Rice Protein, Alcohol SDA-40, Dimethicone, Octyl Salicylate, Cetyl Alcohol, Methicone, Sodium Laureth Sulfate, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Fragrance, Triethanolamine, Stearic Acid, Lecithin, Alumina, Caprylyl Glycol, Methylisothiazolinone.
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL - 58 mL Tube Label
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INGREDIENTS AND APPEARANCE
SKIN RESEARCH INSTITUTE NATURALLY BASED SUNSCREEN SPF 30
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-6504 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Isocetyl Stearate (UNII: 3RJ7186O9W) Sorbitol (UNII: 506T60A25R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Acetyl Hexapeptide-8 (UNII: L4EL31FWIL) Dimethicone (UNII: 92RU3N3Y1O) Octisalate (UNII: 4X49Y0596W) Cetyl Alcohol (UNII: 936JST6JCN) Methicone (20 Cst) (UNII: 6777U11MKT) Sodium Laureth-3 Sulfate (UNII: BPV390UAP0) Carboxypolymethylene (UNII: 0A5MM307FC) Green Tea Leaf (UNII: W2ZU1RY8B0) Trolamine (UNII: 9O3K93S3TK) Stearic Acid (UNII: 4ELV7Z65AP) Triethoxycaprylylsilane (UNII: LDC331P08E) Aluminum Oxide (UNII: LMI26O6933) Caprylyl Glycol (UNII: 00YIU5438U) Methylisothiazolinone (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66163-6504-2 58 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2019 Labeler - Cosmetic Solutions LLC (807907928)
