Label: PERFECT SHIELD REJUVE SUNSCREEN 100- zinc oxide, octyl methoxycinnamate, octyl salicylate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52554-1116-1, 52554-1116-2 - Packager: CMS LAB 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 May 30, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Warnings
- Do not use when
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Directions
Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection.
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
Children under 6 months of age: ask a doctor
- Keep out of reach of children
- Uses
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Inactive Ingredients
WATER, CYCLOPENTASILOXANE, GLYCERIN, PROPANEDIOL, HOMOSALATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE, 1,2-HEXANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, SORBITAN CAPRYLATE, FRAGRANCE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, DIPROPYLENE GLYCOL, CERAMIDE NP, SUCROSE STEARATE, SODIUM CITRATE, TOCOPHEROL, CHOLESTEROL, STEARIC ACID, CHOLESTERYL MACADAMIATE, PALMITIC ACID, BUTYLENE GLYCOL, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN, DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE, PALMITOYL TRIPEPTIDE-5, OLIGOPEPTIDE-1
- Perfect Shield Rejuve Sunscreen 100
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INGREDIENTS AND APPEARANCE
PERFECT SHIELD REJUVE SUNSCREEN 100
zinc oxide, octyl methoxycinnamate, octyl salicylate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52554-1116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.5 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 g in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 21.14 g in 50 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52554-1116-2 1 in 1 CARTON 05/30/2018 1 NDC:52554-1116-1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/30/2018 Labeler - CMS LAB Inc (557795012) Registrant - CMS LAB Inc (557795012) Establishment Name Address ID/FEI Business Operations CMS LAB Inc 557795012 relabel(52554-1116) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(52554-1116)