Label: MATTE AND CLEAR MATIFYING PROTECTOR SPF 25- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 69435-1610-1 - Packager: Peer Pharm Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 25, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
To Use: Smooth onto face.
For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses.Water, Cetearyl Alcohol & Cetearyl Glucoside, Cyclopentasiloxane, Isohexadecane, Stearate & Peg-100 stearate, Glycerin, Simmondsia Chimensis (Jojoba) seed oil, Butyrospermum Parkii (shea) Butter, Potassim Cetyl Phosphate, Niacinamide (Vit.B3), Dehydroacetic Acid & Benzoic Acid & Phenoxyethanol, Dimethicone, Maris Sal (from dead sea), * Fragrance (supplement) , Allantoin, Aloe Barbadensis (Aloe Vera) Leaf extract, Retinyl Palmitate, Persea Grattissima, Olea Europaea (Olive) fruit oil, Tocopheryl Acetate (vit.E), Panthenol (vit. B5), Anthemis Nobilis (Chamomile) extract, Punica Granatum (Pomegranate) extract, Camelia Sinensis extract.
-
INGREDIENTS AND APPEARANCE
MATTE AND CLEAR MATIFYING PROTECTOR SPF 25
octinoxate, octocrylene, octisalate, avobenzone, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1610 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISOHEXADECANE (UNII: 918X1OUF1E) GLYCERIN (UNII: PDC6A3C0OX) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) SHEA BUTTER (UNII: K49155WL9Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) NIACINAMIDE (UNII: 25X51I8RD4) DIMETHICONE (UNII: 92RU3N3Y1O) SEA SALT (UNII: 87GE52P74G) ALOE VERA LEAF (UNII: ZY81Z83H0X) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) CAMELINA SATIVA WHOLE (UNII: W42JFE4HON) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69435-1610-1 50 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/23/2016 Labeler - Peer Pharm Ltd. (514678390) Registrant - Peer Pharm Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharm Ltd. 514678390 manufacture(69435-1610)