PERFECT SHIELD REJUVE SUNSCREEN 100- zinc oxide, octyl methoxycinnamate, octyl salicylate, titanium dioxide cream 
CMS LAB Inc

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.

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Perfect Shield Rejuve Sunscreen 100

Active Ingredient

Zinc Oxide (9%) ------------------------------- Sunscreen
Octinoxate (6%) ------------------------------- Sunscreen
Octisalate (4%) -------------------------------- Sunscreen
Titanium Dioxide (2%) ----------------------- Sunscreen

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use when

skin is red, inflamed, irritated, or painful

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

Helps prevent sunburn

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

Perfect shield

PERFECT SHIELD REJUVE SUNSCREEN 100 
zinc oxide, octyl methoxycinnamate, octyl salicylate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 21.14 g  in 50 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52554-1116-21 in 1 CARTON05/30/2018
1NDC:52554-1116-150 mL in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/30/2018
Labeler - CMS LAB Inc (557795012)
Registrant - CMS LAB Inc (557795012)
Establishment
NameAddressID/FEIBusiness Operations
CMS LAB Inc557795012relabel(52554-1116)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(52554-1116)

Revised: 5/2018
Document Id: 6d75f235-a636-ad7d-e053-2991aa0a5542
Set id: 6d75f235-a635-ad7d-e053-2991aa0a5542
Version: 2
Effective Time: 20180530
 
CMS LAB Inc