Label: POWERPROOF SUNSCREEN 100- homosalate, octinoxate, zinc oxide, titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 52554-1112-1, 52554-1112-2 - 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 November 6, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
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
-
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
-
INGREDIENTS AND APPEARANCE
POWERPROOF SUNSCREEN 100
homosalate, octinoxate, zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52554-1112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 2.5 g in 50 mL Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 2.5 in 50 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2 g in 50 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.45 g in 50 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52554-1112-2 1 in 1 PACKAGE 11/01/2017 1 NDC:52554-1112-1 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 11/01/2017 Labeler - CMS LAB Inc. (557795012) Registrant - CMS LAB Inc. (557795012) Establishment Name Address ID/FEI Business Operations CMS LAB Inc. 557795012 relabel(52554-1112) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(52554-1112)
