POWERPROOF SUNSCREEN 100- homosalate, octinoxate, zinc oxide, 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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Powerproof Sunscreen 100

Active ingredients

Homosalate (5%)

Octinoxate (5%)

Zinc Oxide (4%)

Titanium Dioxide (2.52%)

Purpose

Sunscreen

Uses

Helps prevent sunburn

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

When using this product do not apply on other parts of the body do not use on damaged or broken skin avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water do not apply directly to wound or open cut

Stop use and ask a doctor if Rash or irritation on skin develops and lasts

Keep out of reach of children

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

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. the palm of the hands and pat lightly with the fingertips.

- 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

Inactive ingredients

WATER, CYCLOPENTASILOXANE, DISILOXANE, ALCOHOL, METHICONE, DIBUTYL ADIPATE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, DIPROPYLENE GLYCOL, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, PROPANEDIOL, 1,2-HEXANEDIOL, PORTULACA OLERACEA EXTRACT, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CALCIUM ALUMINUM BOROSILICATE, SACCHARIDE HYDROLYSATE, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, SALVIA HISPANICA SEED EXTRACT, METHYL METHACRYLATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TOCOPHEROL, SILICA, CETEARYL DIMETHICONE CROSSPOLYMER, OCTYLDODECANOL, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, POLYMETHYLSILSESQUIOXANE, POLYGLYCERYL-6 POLYRICINOLEATE, PEG-10 DIMETHICONE, PANTHENOL, SODIUM CHLORIDE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, PALMITIC ACID, CHOLESTERYL MACADAMIATE, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN, SODIUM HYALURONATE

Powerproof Sunscreen 100

powerproof sunscreen 100

POWERPROOF SUNSCREEN 100 
homosalate, octinoxate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate2.5 g  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.5   in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.45 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
ALCOHOL (UNII: 3K9958V90M)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
PROPANEDIOL (UNII: 5965N8W85T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PURSLANE (UNII: M6S840WXG5)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
INVERT SUGAR (UNII: ED959S6ACY)  
TURMERIC (UNII: 856YO1Z64F)  
CHIA SEED (UNII: NU0OLX06F8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52554-1112-21 in 1 PACKAGE11/01/2017
1NDC:52554-1112-150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2017
Labeler - CMS LAB Inc. (557795012)
Registrant - CMS LAB Inc. (557795012)
Establishment
NameAddressID/FEIBusiness Operations
CMS LAB Inc.557795012relabel(52554-1112)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(52554-1112)

Revised: 11/2017
Document Id: d7a17996-5508-41a4-9067-1dfe1b564551
Set id: e9a80816-2f04-45be-96aa-9be2e5e9d2f9
Version: 3
Effective Time: 20171106
 
CMS LAB Inc.