| NDC | 69423-125-50 |
| Set ID | 40bd06e5-5821-6d5c-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | The Procter & Gamble Manufacturing Company |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use water resistant sunscreen if swimming or sweating
-
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 value of 15 or higher and other sun protection measures including:
- limit time in sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: ask a doctor
- Other information
-
Inactive ingredients
water, glycerin, polymethylsilsesquioxane, niacinamide*, polyethylene, pentylene glycol, palmitoyl pentapeptide-4**, panthenol***, ascorbic acid^, tocopheryl acetate^^, camellia sinensis leaf extract^^^, allantoin, carnosine, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, benzyl alcohol, stearyl alcohol, behenyl alcohol, PEG-100 stearate, cetyl alcohol, methylparaben, fragrance, propylparaben, ethylparaben, cetearyl glucoside, cetearyl alcohol, dimethiconol, disodium EDTA, stearic acid, palmitic acid, iodopropynyl butylcarbamate.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
OLAY REGENERIST REGENERATING ADVANCED ANTI-AGING MOISTURIZE BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength PALMITIC ACID (UNII: 2V16EO95H1) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIMETHICONE (UNII: 92RU3N3Y1O) PANTHENOL (UNII: WV9CM0O67Z) CARNOSINE (UNII: 8HO6PVN24W) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALLANTOIN (UNII: 344S277G0Z) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) PEG-100 STEARATE (UNII: YD01N1999R) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DOCOSANOL (UNII: 9G1OE216XY) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BENZYL ALCOHOL (UNII: LKG8494WBH) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-125-50 1 in 1 CARTON 11/01/2016 1 50 mL in 1 BOTTLE, PUMP; 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 11/01/2016 Labeler - The Procter & Gamble Manufacturing Company (004238200)
