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

Perfect Shield Rejuve Sunscreen 100 by

Drug Labeling and Warnings

Perfect Shield Rejuve Sunscreen 100 by is a Otc medication manufactured, distributed, or labeled by CMS LAB Inc, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PERFECT SHIELD REJUVE SUNSCREEN 100 
zinc oxide, octyl methoxycinnamate, octyl salicylate, titanium dioxide cream

Product 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)