Label: SUN SCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70445-158-01 - Packager: Webb Business Promotions
- 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 October 18, 2016
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- Purpose
- Drug Facts
- Directions
- Warnings
- Inactive Ingredients
- SPF 30 Sunscreen Lotion-1oz ASI95838 Made in China
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INGREDIENTS AND APPEARANCE
SUN SCREEN
octinoxate, octisalate, oxybenzone, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70445-158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength DMDM HYDANTOIN (UNII: BYR0546TOW) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CETETH-25 (UNII: 5KLY4IOG20) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70445-158-01 5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/11/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2009 Labeler - Webb Business Promotions (154445647) Establishment Name Address ID/FEI Business Operations Webb Business Promotions 154445647 manufacture(70445-158)
