Label: SPF 30 SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 71160-011-00 - Packager: Tekweld Solutions, Inc.
- 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 December 26, 2019
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- Insect Repellent Active Ingredient: Soybean oil 3% Inactive ingredients
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INGREDIENTS AND APPEARANCE
SPF 30 SUNSCREEN
octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71160-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOCETYL PALMITATE (UNII: 355356620Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DMDM HYDANTOIN (UNII: BYR0546TOW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71160-011-00 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/22/2017 Labeler - Tekweld Solutions, Inc. (029077754)